A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women

Study Overview
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Brief Summary
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Multi-center, prospective, within-subject control, open label clinical trial to evaluate the durability of the safety and effectiveness of the Eclipse™ System after 3 and 12 months of use.

Official Title
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A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women

Conditions
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Fecal Incontinence

Intervention / Treatment
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* Device: Eclipse™ System


Participation Criteria
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Eligibility Criteria
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Abbreviated Inclusion Criteria: History of Fecal Incontinence (FI) for at least 6 months Subject willing and able to give written informed consent to participate in the study Subject can read, write and communicate fluently in English Subject willing and able to comply with visit schedule Subject is able to physically manage the insertion and removal of the Insert Abbreviated Exclusion Criteria: Vaginal childbirth within the last 18 months Currently pregnant or planning pregnancy during the study period Acute infections or genito-urinary injuries that would impact comfortable device use Current treatment for Fecal Incontinence other than medical management Removal or diversion of any portion of the bowel Recent urogenital or colorectal surgeries Chronic abdominal pain in absence of diarrhea Chronic (>6 mos) rectal, anal or pelvic pain Chronic watery diarrhea, unmanageable by drugs or diet Inflammatory Bowel Disease (IBD) such as Chron's or Ulcerative Colitis Rectal prolapse (mucosal or full thickness) Grade III or IV hemorrhoids Pelvic organ prolapse beyond the plane of the hymen Concurrent use of intra-vaginal pessary or other device Anal or pelvic malignancy within last 5 years History of pelvic irradiation for cancer Other significant medical or lifestyle factors that could confound the interpretation of the primary endpoint or increase subject risk

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>Eclipse™ System | Device: Eclipse™ System<br>* The Eclipse System is a vaginal bowel control (VBC) therapy intended to provide bowel control for women with fecal incontinence. It is comprised of a non-surgical device placed in the vagina (referred to as the Eclipse Insert) and a pressure-regulated pump which is used to inflate and deflate the Insert. A Sizing Kit, for use during the fitting process, and an evaluation Insert (referred to as the Trial Insert) are also part of the Eclipse System.<br>* Other names: Vaginal Bowel Control (VBC) Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of Treatment Responders in the Intent to Treat (ITT) Cohort | Count of patients with >50% reduction in the average number of FI episodes per week as compared to baseline. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of Treatment Responders in the Per Protocol (PP) Population | Count of patients with >50% reduction in the average number of FI episodes per week as compared to Baseline. | 3, 6 and 12 months | 
| Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline | Change in mean scores on subject-reported outcomes related to symptom severity as reported by St. Mark's (Vaizey) Incontinence Severity Score. St. Mark's is a validated scale widely used in fecal incontinence research. The scale has a 24 point range where 0 = total fecal continence (better outcome) and 24 = total fecal incontinence (worse outcome). A reduction in the St. Mark's score is a better outcome. | 12 months | 
| Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline | Change in mean score (from Baseline) on subject-reported outcomes as reported by FIQoL (Fecal Incontinence Quality of Life) score. The FIQoL scale asks a number of Fecal Incontinence (FI) related questions. Patient responses are rated from 1 to 4 points except one question which is rated from 1 to 5 points. The questions fall into four subscales: lifestyle, coping/behavior, depression/self-perception and embarrassment. The score for each subscale is the average of the responses in that group. For depression/self-perception the subscale score is from 1.0 to 5.0. The other subscale scores are from 1.0 to 4.0. The total FIQoL score is the sum of all four subscales, ranging from 4 to 17. For each subscale and the combined score, lower values indicate worse quality of life and higher values indicate better quality of life. An increase in score as compared to Baseline is therefore a better outcome. | 12 months | 
| Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores | The Patient Global Impression of Improvement (PGI-I) is a scale which describes the patient's perception of how their symptoms have change from Baseline. The scale has a range of 7 points from 1 to 7, where 1 = very much better than Baseline and 7 = very much worse than Baseline and 4 = no change from Baseline. A score below 4 is a better outcome and a score above 4 is a worse outcome, and a score of 4 is a neutral outcome. Note that because the patient is being asked to compare their symptoms to Baseline, no data is taken for this scale at Baseline and the score is an absolute value, not a change from a previous score. | 3, 6, 9 and 12 months |