## Protocol Section
### Identification Module
**NCT ID:** NCT03436979

**Brief Title:** The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse

**Official Title:** The NeuGuide™ System for Vaginal Colpopexy in the Treatment of Uterine Prolapse Post-Market Surveillance Clinical Study

#### Organization Study ID Info
**ID:** 06-CLP-0098
#### Organization
**Class:** INDUSTRY
**Full Name:** Pop Medical Solutions
### Status Module
#### Completion Date
**Date:** 2024-08-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2023-11-22

**Type:** ACTUAL

**Last Update Submit Date:** 2023-11-21

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2023-10-30

**Type:** ACTUAL

#### Start Date
**Date:** 2018-01-01

**Type:** ACTUAL

**Status Verified Date:** 2023-11

#### Study First Post Date
**Date:** 2018-02-19
**Type:** ACTUAL
**Study First Submit Date:** 2018-01-23
**Study First Submit QC Date:** 2018-02-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Pop Medical Solutions

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** False

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The objective of the study is to assess the long term safety, durability of clinical effectiveness and cost effectiveness of the NeuGuide™ system when used for vaginal colpopexy in the treatment of uterine prolapse.

### Conditions Module

**Conditions:**

- Uterine Prolapse Without Vaginal Wall Prolapse

**Keywords:**

- prolapse

- sacrospinous fixation

- minimally invasive

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Subjects who are undergoing surgical treatment for uterine prolapse will be included in the study and will be treated using the NeuGuide™ System.

**Intervention Names:**

- Device: NeuGuide™ System

**Label:** Subjects

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Subjects

**Description:** The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor.

**Name:** NeuGuide™ System

**Other Names:**

- transvaginal sacrospinous ligament fixation

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Primary composite performance outcome

**Measure:** A composite of the Pelvic Organ Prolapse Quantification (POP-Q) C point score, patient-rated symptom of vaginal bulging after vaginal colpopexy performed using the NeuGuide™ and the absence of further surgical therapy for uterine prolapse.

**Time Frame:** 12 months

**Description:** Primary safety of surgical implantation as reflected by adverse events

**Measure:** The number of device / procedure related Serious Adverse Events (SAE).

**Time Frame:** 30 days

**Description:** Primary safety of NeuGuide treatment as reflected by adverse events

**Measure:** The number of Serious Adverse Events and Adverse Events.

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Secondary anatomical performance of the NeuGuide treatment

**Measure:** Change in mean POP-Q C point score from baseline (cm).

**Time Frame:** one month

**Description:** Secondary anatomical performance of the NeuGuide treatment

**Measure:** Change in mean POP-Q C point score from baseline (cm).

**Time Frame:** 6 months

**Description:** Secondary anatomical of the NeuGuide treatment

**Measure:** Change in mean POP-Q C point score from baseline (cm).

**Time Frame:** 12 months

**Description:** Secondary anatomical performance of the NeuGuide treatment outcome

**Measure:** Change in mean POP-Q C point score from baseline (cm).

**Time Frame:** 24 months

**Description:** Secondary anatomical performance of the NeuGuide treatment

**Measure:** Change in mean POP-Q C point score from baseline (cm).

**Time Frame:** 36 months

**Description:** Secondary performance: durability of the NeuGuide treatment

**Measure:** Number of subjects who require surgical therapy of uterine prolapse or urinary incontinence.

**Time Frame:** 36 months

**Description:** Secondary symptomatic performance of the NeuGuide treatment

**Measure:** Number of subjects in whom the primary symptomatic reason for repair of prolapse persists.

**Time Frame:** 12 months

**Description:** Secondary outcome: Cost performance of the procedure

**Measure:** The time utilization of staff performing the NeuGuide procedure.

**Time Frame:** one month

**Description:** Secondary outcome: POP-Q Stage Score.

**Measure:** The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen

**Time Frame:** Baseline

**Description:** Secondary outcome: POP-Q Stage Score.

**Measure:** The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen

**Time Frame:** one month

**Description:** Secondary outcome: POP-Q Stage Score.

**Measure:** The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen

**Time Frame:** 12 months

**Description:** Secondary outcome: POP-Q Stage Score.

**Measure:** The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen

**Time Frame:** 24 months

**Description:** Secondary outcome: POP-Q Stage Score.

**Measure:** The POP-Q Stage Score calculated from POP-Q measurements, where the Stages of POP-Q system measurement are as follows: Stage 0 no prolapse is demonstrated Stage 1 the most distal portion of the prolapse is more than 1 cm above the level of the hymen

**Time Frame:** 36 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. Patient with POP-Q C point greater than (-) 1 cm.
2. Patients who have previously had a partial hysterectomy in which the cervix is intact may be included in this study.
3. Non-pregnant female (female of child bearing potential must have a negative pregnancy test).
4. Patient understands the nature and potential hazards of the procedure and provides written informed consent prior to any study specific assessments.
5. Patient is able to complete written questionnaires.
6. Patient is willing and able to comply with the specified study requirements and follow-up assessments, and can be contacted by telephone.

Exclusion Criteria:

1. Known diagnosis of reproductive tract abnormalities.
2. Prior pelvic radiation therapy, any malignancy or active pelvic inflammatory disease.
3. Known history of severe Pelvic Inflammatory Disease (PID).
4. Prior total hysterectomy.
5. Prior pelvic prolapse surgery using synthetic mesh.
6. Pathological PAP in the past year.
7. Moderate or severe bacterial cervicitis.
8. Moderate or severe pelvic pain (\> 3 on VAS).
9. Severe morbid obesity (BMI \>45).
10. Temperature \> 38°C (oral or equivalent), sepsis, or active infection requiring IV anti-microbial treatment.
11. Significant cognitive impairment.
12. Active malignancy other than non-melanoma skin cancer.
13. Planned surgery (more than a minor one) in the next 30 days.
14. Patient has a known hypersensitivity to device materials (Nickel, suture material).
15. Moribund patient or patient with severe or deteriorating damage in critical body systems.
16. Any condition that in the judgment of the investigators would interfere with the subject's ability to provide informed consent, comply with study instructions, place the subject at increased risk, or which might confound interpretation of study results.
17. Concurrent enrollment in another device or drug trial that has not completed the primary endpoint or clinically interferes with the current study endpoints.

**Gender Based:** True

**Gender Description:** Must have uterine prolapse

**Maximum Age:** 84 Years

**Minimum Age:** 36 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Subjects who are undergoing surgical treatment for uterine prolapse.

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Washington

**Country:** United States

**Facility:** MedStar Health Research Institute

**State:** District of Columbia

**Zip:** 20010

**Location 2:**

**City:** Fort Lauderdale

**Country:** United States

**Facility:** Holy Cross Hospital

**State:** Florida

**Zip:** 33364

**Location 3:**

**City:** Weston

**Country:** United States

**Facility:** Cleveland Clinic Florida

**State:** Florida

**Zip:** 33331

**Location 4:**

**City:** Cambridge

**Country:** United States

**Facility:** Mount Auburn Hospital

**State:** Massachusetts

**Zip:** 02138

**Location 5:**

**City:** Brooklyn

**Country:** United States

**Facility:** Maimonides Medical Center

**State:** New York

**Zip:** 11220

**Location 6:**

**City:** Valley Stream

**Country:** United States

**Facility:** South Nassau Community Hospital Cancer Center

**State:** New York

**Zip:** 11580

**Location 7:**

**City:** Cleveland

**Country:** United States

**Facility:** Cleveland Clinic Cleveland

**State:** Ohio

**Zip:** 44195

**Location 8:**

**City:** Allentown

**Country:** United States

**Facility:** The Institute for Female Pelvic Medicine and Reconstructive Surgery

**State:** Pennsylvania

**Zip:** 18103

**Location 9:**

**City:** Newtown

**Country:** United States

**Facility:** Female Pelvic Health Center

**State:** Pennsylvania

**Zip:** 18940

**Location 10:**

**City:** Dallas

**Country:** United States

**Facility:** Walnut Hill OB/GYN Associates

**State:** Texas

**Zip:** 75231

**Location 11:**

**City:** Falls Church

**Country:** United States

**Facility:** INOVA Women's Hospital

**State:** Virginia

**Zip:** 22046

**Location 12:**

**City:** Berlin-Tempelhof

**Country:** Germany

**Facility:** St. Joseph Krankenhaus

**Location 13:**

**City:** Berlin-Zehlendorf

**Country:** Germany

**Facility:** Krankenhaus Waldfriede

**Zip:** 14163

**Location 14:**

**City:** München

**Country:** Germany

**Facility:** Isar Kliniken GmbH

**Location 15:**

**City:** Be'er Sheva

**Country:** Israel

**Facility:** Soroka Medical Center

#### Overall Officials

**Official 1:**

**Affiliation:** MAXIS Medical

**Name:** James C Leiter, M.D.

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**Description:** There is no plan to make individual participant data a available to other researchers.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000014591

- Term: Uterine Diseases

- ID: D000005831

- Term: Genital Diseases, Female

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000091662

- Term: Genital Diseases

- ID: D000056887

- Term: Pelvic Organ Prolapse

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M14261

- Name: Prolapse

- Relevance: HIGH

- As Found: Prolapse

- ID: M17344

- Name: Uterine Prolapse

- Relevance: HIGH

- As Found: Uterine Prolapse

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M17339

- Name: Uterine Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8943

- Name: Genital Diseases, Female

- Relevance: LOW

- As Found: Unknown

- ID: M2876

- Name: Genital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M28618

- Name: Pelvic Organ Prolapse

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014596

- Term: Uterine Prolapse

- ID: D000011391

- Term: Prolapse

### Misc Info Module

- Version Holder: 2024-05-24
