Pursuit: Real World Use of the Eclipse System

Not Applicable

• Conditions: Fecal Incontinence
• Interventions: Device: Eclipse Insert

• Registration Number: NCT03940573
• Lead Sponsor: Pelvalon, Inc.

Brief Summary

A prospective, open label post-market registry to collect Patient Reported Outcomes and Fitting metrics (e.g. sizes used) in subjects using the Eclipse System in a commercial setting.

Detailed Description

Up to 150 subjects enrolled, in up to 25 sites. Population of all adult female patients with Fecal Incontinence (FI) who present at, or are identified at, participating sites are eligible. This includes patients who are newly prescribed Eclipse, and those already using Eclipse who return for an annual renewal visit during the enrollment period.

Includes fitting of the patient for the Eclipse System with collection of relevant health history data. Patients are provided a temporary device for a trial usage period. Multiple device sizes may be attempted to find the correct fit for the patient, at which point the patient is provided with the long term use Eclipse Insert and enters the treatment period.

During the fitting and treatment period, patient experience will be assessed by surveys, St. Mark's (Vaizey) scores, and the validated global PGI-I index (Patient Global Impression of Improvement). Surveys will be perform at the fitting follow up and at 12 months of device usage, and optionally at 3, 6, and 9 months of device usage.

Study Timeline

• Study Start: 2019-04-19
• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-03
• Study First Posted: 2019-05-07
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-11
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

1. Adult female
2. Diagnosis of Fecal Incontinence
3. Clinician recommendation of the Eclipse System
4. Subject provides informed consent and HIPAA authorization

No Exclusion Criteria.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Eclipse Insert	All patients fitted with the device.

Primary Outcome Measures

Name	Time	Method
Fit Rate	Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening	Proportion of patients successfully fit
Device Size Distribution	Data collected at fitting visits (max 3 attempts), 5-7 weeks from initial screening	Size distribution of devices among successfully fit patients
St. Mark's Score (Vaizey)	12 months	Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)
PGI-I Score	12 months	Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)

Secondary Outcome Measures

Name	Time	Method
PGI-I Score	9 months	Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)
St. Mark's Score (Vaizey)	9 months	Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence)

Trial Locations

Locations (6)

Princeton Urogynecology; 🇺🇸 Princeton, New Jersey, United States

The American Association of Female Pelvic Medicine; 🇺🇸 Agoura Hills, California, United States

Mayo Clinic Jacksonville; 🇺🇸 Jacksonville, Florida, United States

The Ob-Gyn and Incontinence Center; 🇺🇸 Arcadia, California, United States

Long Beach Urogynecology; 🇺🇸 Long Beach, California, United States

Florida Urogynecology, LLC; 🇺🇸 Jacksonville, Florida, United States