Pursuit: Real World Use of the Eclipse System

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: Eclipse Insert


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female Diagnosis of Fecal Incontinence Clinician recommendation of the Eclipse System Subject provides informed consent and HIPAA authorization No Exclusion Criteria.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>All patients fitted with the device. | Device: Eclipse Insert<br>* Rectal Control System.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| St. Mark's Score (Vaizey) | Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence) | 3 months | 
| St. Mark's Score (Vaizey) | Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence) | 6 months | 
| St. Mark's Score (Vaizey) | Change from baseline in mean scores (scored 0-24 with 0 = total continence and 24 = total incontinence) | 9 months | 
| PGI-I Score | Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse) | 3 months | 
| PGI-I Score | Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse)e | 6 months | 
| PGI-I Score | Patient global impression of improvement score (7 point scale comparing current condition to baseline, from 1 = very much better to 7 = very much worse) | 9 months |