## Protocol Section
### Identification Module
**NCT ID:** NCT00521079

**Acronym:** EMPOWER

**Brief Title:** EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

**Official Title:** EMPOWER Clinical Trial: Vagal Blocking for Obesity Control

#### Organization Study ID Info
**ID:** D00343-000
#### Organization
**Class:** INDUSTRY
**Full Name:** ReShape Lifesciences
### Status Module
#### Completion Date
**Date:** 2018-05

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-08-24

**Type:** ACTUAL

**Last Update Submit Date:** 2018-07-26

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2009-10

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-02-20

**Type:** ACTUAL

**Results First Submit Date:** 2016-08-23

**Results First Submit QC Date:** 2016-12-28

#### Start Date
**Date:** 2007-08

**Status Verified Date:** 2018-05

#### Study First Post Date
**Date:** 2007-08-27
**Type:** ESTIMATED
**Study First Submit Date:** 2007-08-23
**Study First Submit QC Date:** 2007-08-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** ReShape Lifesciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** This is a randomized multi-center study being done to measure the ability of a new medical device, Maestro System, to safely reduce body weight over five years in people who are considered obese.

**Detailed Description:** The Maestro System is a neuromodulation system that consists of implantable and external components.

Implantable components: two leads (one electrode each for the anterior and posterior intra-abdominal vagal nerve trunks) that are connected to an implantable neuroregulator.

External components: one programmable, battery-powered, ambulatory external controller connected via a small, flexible cable to a cutaneous transmit coil that is positioned externally over the neuroregulator. A clinician programmer that transmits information to the controller and uploads data from the controller.

All non-diabetic subjects will be randomized in a 2:1 allocation to therapy ON or therapy OFF groups. All type 2 diabetes mellitus subjects will be randomized in a 1:1 allocation to therapy ON or therapy OFF groups.

All subjects will receive blinded therapy through the 12-month follow-up visit. All subjects will participate in a medical weight management program.

### Conditions Module

**Conditions:**

- Obesity

**Keywords:**

- Obesity

- Bariatric surgery

- Excess weight loss

- Vagus nerve

- Vagal blocking

- vBloc(TM) therapy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 294

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).

**Intervention Names:**

- Device: Therapy ON

**Label:** vBloc

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).

**Intervention Names:**

- Device: Therapy OFF

**Label:** Placebo

**Type:** SHAM_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- vBloc

**Description:** Intermittent, programmable, intra-abdominal vagal blocking device that delivers therapy (Therapy ON)

**Name:** Therapy ON

**Other Names:**

- Maestro System

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Active intra-abdominal placebo device that delivers no therapy (Therapy OFF)

**Name:** Therapy OFF

**Other Names:**

- Maestro System

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Observe at least a 10% greater percentage excess weight loss (%EWL) with vBloc therapy delivered by the Maestro System compared to sham 12 months following randomization using MetLife Method (ideal body weight is calculated based on Metropolitan Height and Weight Tables)

**Measure:** Percentage of Excess Weight Loss (EWL) With the Maestro System

**Time Frame:** Baseline and 1 Year

**Description:** To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.

**Measure:** Rate of System and Procedure-related Serious Adverse Events (SAEs).

**Time Frame:** 1 Year

#### Secondary Outcomes

**Description:** To evaluate the percentage of participants achieving 25% excess weight loss from baseline (implant) to 12 months between treatment groups.

**Measure:** Percentage of Participants Achieving 25% Excess Weight Loss (%EWL)

**Time Frame:** Baseline and 1 Year

### Eligibility Module

**Eligibility Criteria:** Inclusion criteria

1. Informed consent.
2. Body mass index (BMI) ≥ 40 kg/m2 to 45 kg/m2 or BMI ≥ 35 kg/m2 to 39.9 kg/m2 with one or more obesity related co-morbid condition. Co-morbid conditions may include one or more of the following:

   * Type 2 diabetes mellitus (note: type 2 diabetics are allowed at selected centers only, see Inclusion criterion #5)
   * Hypertension as defined by systolic pressure ≥140 mmHg and/or diastolic pressure ≥90 mmHg a) treated or untreated with systolic ≥140 mmHg or diastolic ≥90 mmHg or b) treated with systolic \<140 mmHg and diastolic \<90 mmHg
   * Dyslipidemia as defined by total cholesterol ≥200 or LDL ≥130 a) treated or untreated with total cholesterol ≥200 or LDL ≥130 or b) treated with total cholesterol \<200 or LDL \<130
   * Sleep apnea syndrome (confirmed by overnight p02 studies)
   * Obesity related cardiomyopathy
3. Females or males Note: females of child-bearing potential must have a negative urine pregnancy test at Screen and also within 14 days of implant procedure followed by physician-approved contraceptive regimen for the duration of the study period.
4. 18-65 years of age inclusive.
5. Type 2 diabetes mellitus subjects (at selected centers, limited to approximately 34 subjects) with:

   * Glycosylated hemoglobin (Hb A1c) 6.5 - 9 % inclusive at screening visit.
   * Onset: 10 years or less since initial diagnosis.
   * Stable treatment regimen: no change in oral hypoglycemic treatment regimen within past 3 months.
   * Currently not using insulin therapy, GLP-1 receptor agonists (e.g., exenatide), or DPP-4 inhibitors (e.g., sitagliptin) for diabetes treatment and have not been on these treatments in the past 6 months.
   * Creatinine within normal reference range.
   * No history of proliferative retinopathy.
   * No history of peripheral neuropathy.
   * No history of autonomic neuropathy.
   * No history of coronary artery disease, with or without angina pectoris.
   * No history of peripheral vascular disease.
6. Failure to respond to supervised diet/exercise program(s) in which the subject was engaged for at least 6 months within the last five years.
7. Ability to complete all study visits and procedures.

Exclusion criteria

1. Concurrent chronic pancreatic disease.
2. History of Crohn's disease and/or ulcerative colitis.
3. History of bariatric surgery, fundoplication, gastric resection or major upper-abdominal surgery (acceptable surgeries include cholecystectomy, hysterectomy).
4. History of pulmonary embolism or blood coagulation disorders.
5. Clinically significant hiatal hernias known from subject's medical record as or determined by upper endoscopy prior to implant if they have not had one done during the previous 6 months that specifically reported on the presence or absence of hiatal hernia making reference to the Z-line and/or diaphragmatic notch, in order to rule out subjects with hiatal hernia that may require surgical repair (to support exclusion criterion #7).
6. Current portal hypertension and/or esophageal varices.
7. Intra-operative exclusion: hiatal hernia requiring surgical repair or extensive dissection at esophagogastric junction at time of surgery.
8. Treatment with weight-loss prescription drug therapy within the prior three months and the use of prescription drug therapy or the use over-the-counter weight loss preparations for the duration of the trial.
9. Smoking cessation within the prior six months.
10. Known genetic cause of obesity (e.g., Prader-Willi Syndrome).
11. Overall sustained reduction of more than 10% of body weight in the previous 12 months.
12. Physician-prescribed pre-operative diet with intent to lose weight prior to surgery (note: a) study subject may continue any personal diet they were on prior to study enrollment \[see exclusion criterion #24\] b) standardized EMPOWER weight management program to be initiated in all subjects at time of activation, approximately two weeks after implant)
13. Current type 1 diabetes mellitus (DM).
14. Current or recent history (within 12 months) of ongoing bulimia.
15. Current alterations in treatment for thyroid disorders (stable treatment regimen for prior three months acceptable).
16. Current alterations in treatment for epilepsy (stable treatment regimen for prior six months acceptable).
17. Current treatment for peptic ulcer disease (previous history acceptable).
18. Chronic (more than 4 weeks of daily use) treatment with narcotic analgesic drug regimens (treatment with non-steroidal anti-inflammatory drugs acceptable).
19. Current alterations in treatment regimens of anti-cholinergic drugs, including tricyclic antidepressants (stable treatment regimen for prior six months acceptable).
20. Current medical condition that, in the opinion of the investigator, would make subject unfit for surgery under general anesthesia or that would be exacerbated by intentional weight loss. Some examples include diagnosis of cancer, recent heart attack, recent stroke or recent serious trauma.
21. Presence of permanently implanted electrical powered medical device or implanted gastrointestinal device or prosthesis (e.g., pacemakers, implanted defibrillators, neurostimulators etc.).
22. Planned or contemplated use of Magnetic Resonance Imaging (MRI) or oncological radiation during the course of the trial.
23. Significant psychiatric disorders that, in the opinion of the investigator, may interfere with subject's ability to follow study procedures and/or instructions.
24. Current, active member of an organized weight loss program (e.g., Weight Watchers, TOPS).
25. Current participant in another weight loss study or other clinical trials.
26. Have a friend or family member who is currently participating or is planning to participate in this clinical trial.
27. Patient reported:

    * inability to walk for about 10 minutes without stopping,
    * feeling of pain in chest when doing physical activity,
    * feeling of pain in chest when not doing physical activity. Note: unless pain in chest in known to be related to upper gastrointestinal disorders such as gastroesophageal reflux disease or heartburn.
28. Clinically significant cardiac rhythm disorder that requires either medical and/or surgical intervention (e.g., paroxysmal or chronic atrial fibrillation).

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Scottsdale

**Country:** United States

**Facility:** HonorHealth (formerly Scottsdale Bariatric Center)

**State:** Arizona

**Zip:** 85258

**Location 2:**

**City:** La Jolla

**Country:** United States

**Facility:** Scripps Clinic

**State:** California

**Zip:** 92037

**Location 3:**

**City:** Orange

**Country:** United States

**Facility:** University of California, Irvine Medical Center

**State:** California

**Zip:** 92868

**Location 4:**

**City:** Stanford

**Country:** United States

**Facility:** Stanford University Medical Center

**State:** California

**Zip:** 94305

**Location 5:**

**City:** Weston

**Country:** United States

**Facility:** Cleveland Clinic - Florida

**State:** Florida

**Zip:** 33331

**Location 6:**

**City:** Baltimore

**Country:** United States

**Facility:** Johns Hopkins

**State:** Maryland

**Zip:** 21224

**Location 7:**

**City:** Boston

**Country:** United States

**Facility:** Tufts New England Medical Center

**State:** Massachusetts

**Zip:** 02111

**Location 8:**

**City:** Minneapolis

**Country:** United States

**Facility:** University of Minnesota

**State:** Minnesota

**Zip:** 55455

**Location 9:**

**City:** Rochester

**Country:** United States

**Facility:** Mayo Clinic

**State:** Minnesota

**Zip:** 55905

**Location 10:**

**City:** Saint Louis

**Country:** United States

**Facility:** Washington University School of Medicine

**State:** Missouri

**Zip:** 63110

**Location 11:**

**City:** Cleveland

**Country:** United States

**Facility:** Cleveland Clinic - Ohio

**State:** Ohio

**Zip:** 44195

**Location 12:**

**City:** Portland

**Country:** United States

**Facility:** Oregon Health & Science University

**State:** Oregon

**Zip:** 97239-3098

**Location 13:**

**City:** Richmond

**Country:** United States

**Facility:** Virginia Commonwealth University

**State:** Virginia

**Zip:** 23298

**Location 14:**

**City:** Sydney

**Country:** Australia

**Facility:** Institute of Weight Control

**State:** New South Wales

**Zip:** 2153

**Location 15:**

**City:** Bedford Park

**Country:** Australia

**Facility:** Adelaide Bariatric Center - Flinders Private Hospital

**State:** South Australia

**Zip:** 5042

#### Overall Officials

**Official 1:**

**Affiliation:** VA Medical Center, Minneapolis, MN / University of Minnesota

**Name:** Charles J Billington, MD

**Role:** PRINCIPAL_INVESTIGATOR

**Official 2:**

**Affiliation:** Mayo Clinic

**Name:** Michael Sarr, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

### Condition Browse Module - Browse Leaves

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M18102

- Name: Weight Loss

- Relevance: LOW

- As Found: Unknown

- ID: M12701

- Name: Obesity

- Relevance: HIGH

- As Found: Obesity

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000009765

- Term: Obesity

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** Includes roll-in subjects.

#### Event Groups

**Group ID:** EG000

**Title:** vBloc

**Description:** Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).

**ID:** EG000

**Other Num Affected:** 146

**Other Num at Risk:** 192

**Serious Number Affected:** 23

**Serious Number At Risk:** 192

**Title:** vBloc

**Group ID:** EG001

**Title:** Placebo

**Description:** Subjects implanted with a functional Maestro System device that does NOT delivers therapy (Therapy OFF).

**ID:** EG001

**Other Num Affected:** 70

**Other Num at Risk:** 102

**Serious Number Affected:** 12

**Serious Number At Risk:** 102

**Title:** Placebo

**Frequency Threshold:** 5

#### Other Events

**Term:** Bloating Abdominal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Chest Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Primarily related to the sensation of therapy.

Generally occurred early with mild to moderate severity.

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Constipation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Diarrhea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Eructation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Heartburn/Dyspepsia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Incision pain incision site

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

**Source Vocabulary:** 

**Term:** Nausea

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Pain Abdominal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Pain neuroregulator site

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Skin reaction to coil/coil adhesion method

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Wound redness or irritation

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

**Term:** Cold/flu/respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Respiratory, thoracic and mediastinal disorders

**Source Vocabulary:** 

**Term:** Depression

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Energy decreased

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Edema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

**Source Vocabulary:** 

**Term:** Emesis (vomiting)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Out of range lab values

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Vitamin or mineral insufficiency

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Metabolism and nutrition disorders

**Source Vocabulary:** 

**Term:** Cramps abdominal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Reaction to medicines

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Urinary tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Renal and urinary disorders

**Source Vocabulary:** 

**Term:** Anxiety

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

**Term:** Trauma

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Musculoskeletal and connective tissue disorders

**Source Vocabulary:** 

**Term:** Paresthesia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Incision pain incision site

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 192

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 102

**Term:** Infection neuroregulator site

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 2

**Num At Risk:** 192

**Num Events:** 2

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 102

**Num Events:** 1

**Term:** Lead impedance high

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

##### Stats

**Group ID:** EG000

**Num At Risk:** 192

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 102

**Num Events:** 1

**Term:** Neuroregulator malfunction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Surgical and medical procedures

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 192

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 102

**Term:** Pain abdominal

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 3

**Num At Risk:** 192

**Num Events:** 3

**Group ID:** EG001

**Num At Risk:** 102

**Term:** Pain neuroregulator site

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Skin and subcutaneous tissue disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 192

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 102

**Num Events:** 1

**Term:** Bleeding other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Reproductive system and breast disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 192

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 102

**Term:** Cardiac abnormality

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 192

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 102

**Term:** Cold/flu/respiratory tract infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 192

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 102

**Term:** Gallbladder disease

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Hepatobiliary disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 192

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 102

**Term:** Hypertension

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Cardiac disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 192

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 102

**Num Events:** 1

**Term:** Infection other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Infections and infestations

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 192

**Num Events:** 1

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 102

**Num Events:** 1

**Term:** Large bowel dysfunction

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** Gastrointestinal disorders

##### Stats

**Group ID:** EG000

**Num At Risk:** 192

**Group ID:** EG001

**Num Affected:** 1

**Num At Risk:** 102

**Num Events:** 1

**Term:** Other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 8

**Num At Risk:** 192

**Num Events:** 8

**Group ID:** EG001

**Num Affected:** 6

**Num At Risk:** 102

**Num Events:** 6

**Term:** Pain other

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 192

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 102

**Term:** Reaction to medicines

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 192

**Num Events:** 1

**Group ID:** EG001

**Num At Risk:** 102

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 183

**Group ID:** BG001

**Value:** 97

**Group ID:** BG002

**Value:** 280

**Units:** Participants

### Group

**ID:** BG000

**Title:** vBloc

**Description:** Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).

### Group

**ID:** BG001

**Title:** Placebo

**Description:** Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** <=18 years

#### Measurement

**Group ID:** BG000

**Value:** 183

#### Measurement

**Group ID:** BG001

**Value:** 97

#### Measurement

**Group ID:** BG002

**Value:** 280

**Category Title:** Between 18 and 65 years

#### Measurement

**Group ID:** BG000

**Value:** 0

#### Measurement

**Group ID:** BG001

**Value:** 0

#### Measurement

**Group ID:** BG002

**Value:** 0

**Category Title:** >=65 years

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.7

**Value:** 45.7

#### Measurement

**Group ID:** BG001

**Spread:** 10.6

**Value:** 45.6

#### Measurement

**Group ID:** BG002

**Spread:** 10

**Value:** 45.7

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 165

#### Measurement

**Group ID:** BG001

**Value:** 83

#### Measurement

**Group ID:** BG002

**Value:** 248

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 18

#### Measurement

**Group ID:** BG001

**Value:** 14

#### Measurement

**Group ID:** BG002

**Value:** 32

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 142

#### Measurement

**Group ID:** BG001

**Value:** 77

#### Measurement

**Group ID:** BG002

**Value:** 219

**Class Title:** United States

#### Measurement

**Group ID:** BG000

**Value:** 41

#### Measurement

**Group ID:** BG001

**Value:** 20

#### Measurement

**Group ID:** BG002

**Value:** 61

**Class Title:** Australia

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Age, Categorical
**Unit of Measure:** Participants
### Measure 2
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** NUMBER
**Title:** Region of Enrollment
**Unit of Measure:** participants
## Results Section - More Information Module
### Certain Agreement
**Restriction Type:** LTE60
**Restrictive Agreement:** True
### Limitations and Caveats
**Description:** Two confounding efficacy factors: Variable hours of therapy in both arms due to inconsistent external power source use and altered vagal excitability in the control arm due to small electrical inputs delivered to vagal nerves for safety checks.
### Point of Contact
**Email:** ktweden@enteromedics.com
**Organization:** EnteroMedics Inc
**Phone:** 651-634-3209
**Title:** Senior Vice President of Clinical
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2
- **Upper Limit:** 
- **Value:** 17
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2
- **Upper Limit:** 
- **Value:** 16
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 22
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 25
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Observe at least a 10% greater percentage excess weight loss (%EWL) with vBloc therapy delivered by the Maestro System compared to sham 12 months following randomization using MetLife Method (ideal body weight is calculated based on Metropolitan Height and Weight Tables)
**Dispersion Type:** Standard Error
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Baseline and 1 Year
**Title:** Percentage of Excess Weight Loss (EWL) With the Maestro System
**Type:** PRIMARY
**Unit of Measure:** Percentage of excess weight loss
##### Group
**Description:** Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
**ID:** OG000
**Title:** vBloc
##### Group
**Description:** Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 2
**Description:** To estimate the rate of serious, system- and procedure-related adverse events associated with the Maestro System.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** 1 Year
**Title:** Rate of System and Procedure-related Serious Adverse Events (SAEs).
**Type:** PRIMARY
**Unit of Measure:** Events
##### Group
**Description:** Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
**ID:** OG000
**Title:** vBloc
##### Group
**Description:** Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
**ID:** OG001
**Title:** Placebo
#### Outcome Measure 3
**Description:** To evaluate the percentage of participants achieving 25% excess weight loss from baseline (implant) to 12 months between treatment groups.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Baseline and 1 Year
**Title:** Percentage of Participants Achieving 25% Excess Weight Loss (%EWL)
**Type:** SECONDARY
**Unit of Measure:** Percentage of subjects
##### Group
**Description:** Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
**ID:** OG000
**Title:** vBloc
##### Group
**Description:** Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
**ID:** OG001
**Title:** Placebo
### Participant Flow Module
#### Group
**Description:** Subjects implanted with a functional Maestro System device that delivers therapy (Therapy ON).
**ID:** FG000
**Title:** vBloc
#### Group
**Description:** Subjects implanted with a functional Maestro System device that does NOT deliver therapy (Therapy OFF).
**ID:** FG001
**Title:** Placebo
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Adverse Event
###### Reason
**Group ID:** FG000
**Number of Subjects:** 7
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 2
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 5
###### Reason
**Group ID:** FG001
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 192
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 102
##### Milestone
**Type:** Surgical Roll-In
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 5
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 178
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 97
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 14
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 5
**Has Results:** True