## Protocol Section
### Identification Module
**NCT ID:** NCT01107379

**Acronym:** ORIOS 2

**Brief Title:** Optimization and Refinement of Technique in In-Office Sinus Dilation 2

**Official Title:** Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)

#### Organization Study ID Info
**ID:** CPR005010
#### Organization
**Class:** INDUSTRY
**Full Name:** Acclarent
### Status Module
#### Completion Date
**Date:** 2012-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2014-09-18

**Type:** ESTIMATED

**Last Update Submit Date:** 2014-09-13

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2012-01

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2014-09-18

**Type:** ESTIMATED

**Results First Submit Date:** 2014-05-28

**Results First Submit QC Date:** 2014-09-13

#### Start Date
**Date:** 2010-04

**Status Verified Date:** 2014-09

#### Study First Post Date
**Date:** 2010-04-21
**Type:** ESTIMATED
**Study First Submit Date:** 2010-04-12
**Study First Submit QC Date:** 2010-04-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Acclarent

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.

### Conditions Module

**Conditions:**

- Sinusitis

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 203

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Dilation of sinuses using Relieva Balloon Sinuplasty System

**Intervention Names:**

- Device: Relieva Balloon Sinuplasty System

**Label:** Balloon catheter device

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Balloon catheter device

**Description:** Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis

**Name:** Relieva Balloon Sinuplasty System

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data.

The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.

**Measure:** Mean Intra-patient Change in SNOT-20 Score

**Time Frame:** Baseline and 24 weeks

**Description:** Change in Lund-Mackay CT score for paired baseline and 24 week data.

The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden.

**Measure:** Mean Intra-patient Change in Lund-Mackay CT Scan Score

**Time Frame:** Baseline and 24 weeks

#### Secondary Outcomes

**Description:** Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.

**Measure:** Procedure Tolerability

**Time Frame:** Day 0 (Day of Procedure)

**Description:** Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary

**Measure:** Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary

**Time Frame:** Day 0 (Day of Procedure)

**Description:** Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events.

**Measure:** Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.

**Time Frame:** Day 0 (Day of Procedure)

**Description:** Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living

**Measure:** Mean Number of Days to Return to Normal Activities

**Time Frame:** 2 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male/Female, 18 year or older
* Diagnosis of Chronic Rhinosinusitis
* Planned Endoscopic Sinus surgery

Exclusion Criteria:

* Cystic Fibrosis
* Severe Polyposis
* Sinonasal tumors
* History of facial trauma precluding access to sinus ostium
* Ciliary Disfunction
* Planned non-sinus surgery (such as rhinoplasty, septoplasty, etc.)
* Pregnant or lactating female
* Inability to tolerate an awake procedure
* Participation in another investigational clinical study involving treatment for chronic rhinosinusitis

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Adult subjects with diagnosis of CRS and planned endoscopic sinus surgery.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Birmingham

**Country:** United States

**State:** Alabama

**Location 2:**

**City:** Las Vegas

**Country:** United States

**State:** Nevada

**Location 3:**

**City:** Dublin

**Country:** United States

**State:** Ohio

#### Overall Officials

**Official 1:**

**Affiliation:** Alabama Alabama Nasal and Sinus Center

**Name:** Michael Sillers, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Karanfilov B, Silvers S, Pasha R, Sikand A, Shikani A, Sillers M; ORIOS2 Study Investigators. Office-based balloon sinus dilation: a prospective, multicenter study of 203 patients. Int Forum Allergy Rhinol. 2013 May;3(5):404-11. doi: 10.1002/alr.21112. Epub 2012 Nov 7.

**PMID:** 23136057

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012141

- Term: Respiratory Tract Infections

- ID: D000007239

- Term: Infections

- ID: D000010254

- Term: Paranasal Sinus Diseases

- ID: D000009668

- Term: Nose Diseases

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000010038

- Term: Otorhinolaryngologic Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC01

- Name: Infections

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: BC09

- Name: Ear, Nose, and Throat Diseases

### Condition Browse Module - Browse Leaves

- ID: M7292

- Name: Dilatation, Pathologic

- Relevance: LOW

- As Found: Unknown

- ID: M15657

- Name: Sinusitis

- Relevance: HIGH

- As Found: Sinusitis

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14978

- Name: Respiratory Tract Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13167

- Name: Paranasal Sinus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12604

- Name: Nose Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12961

- Name: Otorhinolaryngologic Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012852

- Term: Sinusitis

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Balloon Device

**Description:** Dilation of sinuses using balloon catheter tools

Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses

**ID:** EG000

**Other Num Affected:** 44

**Other Num at Risk:** 203

**Serious Number Affected:** 1

**Serious Number At Risk:** 203

**Title:** Balloon Device

**Frequency Threshold:** 0

#### Other Events

**Term:** Peri-orbital edema

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Procedure-related. Not device related

**Organ System:** Eye disorders

**Source Vocabulary:** 

**Term:** Sinus Infection

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Not device or procedure-related

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

**Source Vocabulary:** 

**Term:** Dysphagia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Not device or procedure related

**Organ System:** Gastrointestinal disorders

**Source Vocabulary:** 

**Term:** Sensorineural Hearing Loss

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Not device or procedure related

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** 

**Term:** Tinnitus

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Not device or procedure-rleated

**Organ System:** Ear and labyrinth disorders

**Source Vocabulary:** 

**Term:** Allergic reaction to medication (antibiotic)

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Not device or procedure-related

**Organ System:** Immune system disorders

**Source Vocabulary:** 

**Term:** Facial Pain

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Not device or procedure-related

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** Headache

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Not device or procedure-related

**Organ System:** General disorders

**Source Vocabulary:** 

#### Serious Events

**Term:** Pneumonia

**Assessment Type:** SYSTEMATIC_ASSESSMENT

**Notes:** Pneumonia occurred approximately 2 months after the procedure. Related to a pre-existing condition. Not device or procedure-related

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

##### Stats

**Group ID:** EG000

**Num Affected:** 1

**Num At Risk:** 203

**Num Events:** 1

**Time Frame:** 1 year

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 203

**Units:** Participants

### Group

**ID:** BG000

**Title:** Balloon Catheter Device

**Description:** Dilation of sinuses using balloon catheter tools

Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for sinus dilation

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 15.4

**Value:** 48.6

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 108

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 95

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 22

**Class Title:** Hispanic/Latino

#### Measurement

**Group ID:** BG000

**Value:** 145

**Class Title:** White/Caucasian

#### Measurement

**Group ID:** BG000

**Value:** 5

**Class Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 22

**Class Title:** Black or African

#### Measurement

**Group ID:** BG000

**Value:** 1

**Class Title:** Native Hawaiian / Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 2

**Class Title:** North American Indian or Inuit

#### Measurement

**Group ID:** BG000

**Value:** 6

**Class Title:** Other (not specified)

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 203

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Race/Ethnicity, Customized
**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:** GT60
**Restrictive Agreement:** True
### Point of Contact
**Email:** lenglan1@its.jnj.com
**Organization:** Acclarent, Inc.
**Phone:** 650-687-5888
**Title:** Clinical Director
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
### Outcome Measure 4
### Outcome Measure 5
### Outcome Measure 6
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.03
- **Upper Limit:** 
- **Value:** -1.16
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 76.3
- **Spread:** 
- **Upper Limit:** 87.4
- **Value:** 163
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 90.91
- **Spread:** 
- **Upper Limit:** 95.13
- **Value:** 552
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 552
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.8
- **Upper Limit:** 
- **Value:** 2.3
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.56
- **Upper Limit:** 
- **Value:** -4.32
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data.

The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 113 subjects.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 24 weeks
**Title:** Mean Intra-patient Change in SNOT-20 Score
**Type:** PRIMARY
**Unit of Measure:** Scores on a scale
##### Group
**Description:** Dilation of sinuses using balloon catheter tools

Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** OG000
**Title:** Balloon Device
#### Outcome Measure 2
**Description:** Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.
**Parameter Type:** NUMBER
**Population Description:** Not all subjects were compliant will filling out tolerability questionnaires. Data are available for 198 subjects.
**Reporting Status:** POSTED
**Time Frame:** Day 0 (Day of Procedure)
**Title:** Procedure Tolerability
**Type:** SECONDARY
**Unit of Measure:** number of participants
##### Group
**Description:** Dilation of sinuses using balloon catheter tools

Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** OG000
**Title:** Balloon Device
#### Outcome Measure 3
**Description:** Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Day 0 (Day of Procedure)
**Title:** Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary
**Type:** SECONDARY
**Type Units Analyzed:** sinuses
**Unit of Measure:** number of sinuses
##### Group
**Description:** Dilation of sinuses using balloon catheter tools

Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** OG000
**Title:** Balloon Device
#### Outcome Measure 4
**Description:** Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** Day 0 (Day of Procedure)
**Title:** Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events.
**Type:** SECONDARY
**Type Units Analyzed:** sinuses
**Unit of Measure:** number of sinuses
##### Group
**Description:** Dilation of sinuses using balloon catheter tools

Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** OG000
**Title:** Balloon Device
#### Outcome Measure 5
**Description:** Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** Not all subjects were compliant with reporting the Number of Days to Return to Normal Activities post procedure. Data are available for 181 subjects.
**Reporting Status:** POSTED
**Time Frame:** 2 weeks
**Title:** Mean Number of Days to Return to Normal Activities
**Type:** SECONDARY
**Unit of Measure:** days
##### Group
**Description:** Dilation of sinuses using balloon catheter tools

Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** OG000
**Title:** Balloon Device
#### Outcome Measure 6
**Description:** Change in Lund-Mackay CT score for paired baseline and 24 week data.

The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** The 24 week follow-up was optional for 83 of the 203 enrolled subjects. Additionally, for those who were expected per protocol to return for the 24 week follow-up, not all did return so that data could be collected. Data are available for 111 subjects.
**Reporting Status:** POSTED
**Time Frame:** Baseline and 24 weeks
**Title:** Mean Intra-patient Change in Lund-Mackay CT Scan Score
**Type:** PRIMARY
**Unit of Measure:** Scores on a scale
##### Group
**Description:** Dilation of sinuses using balloon catheter tools

Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** OG000
**Title:** Balloon Device
### Participant Flow Module
#### Group
**Description:** Dilation of sinuses using balloon catheter tools

Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses
**ID:** FG000
**Title:** Balloon Device
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Withdrawal by Subject
###### Reason
**Group ID:** FG000
**Number of Subjects:** 18
##### Withdraw
**Type:** Lost to Follow-up
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 203
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 182
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 21
**Pre-Assignment Details:** The lead-in cohort (N=36) consisted of each investigator's first cases where all targeted sinuses were successfully dilated (minimum of 3 cases) with the exception of 4 investigators who participated in the prior ORIOS study.
**Has Results:** True