NCT03940573

Pursuit: Real World Use of the Eclipse System

A Registry to Further Develop the Understanding of the Real World Use of the Eclipse System for Fecal Incontinence in Women

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Pelvalon, Inc. · Industry
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Fecal Incontinence

Interventions

Type	Name	Description
DEVICE	Eclipse Insert	Rectal Control System.

Timeline

• Start date: 2019-04-19
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-05-07
• Last updated: 2021-03-11

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study