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

Fecal Incontinence Clinical Trial

— LIBERATE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02428595
• Other study ID #: CA005
• Status: Completed
• Phase: N/A
• Start date: May 15, 2015
• Est. completion date: July 18, 2018

Study information

• Verified date: August 2019
• Source: Pelvalon, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: July 18, 2018
• Est. primary completion date: July 18, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fecal Incontinence

Intervention

Device:
• Eclipse™ System
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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico
United States	University of Alabama	Birmingham	Alabama
United States	Massachusetts General Hospital (MGH)	Boston	Massachusetts
United States	Christ Hospital	Cincinnati	Ohio
United States	Houston Methodist	Houston	Texas
United States	University of Wisconsin	Madison	Wisconsin
United States	University of Oklahoma	Oklahoma City	Oklahoma
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Brown University (WIHRI)	Providence	Rhode Island
United States	University of North Carolina	Raleigh	North Carolina
United States	Providence Sacred Heart	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Pelvalon, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Richter HE, Matthews CA, Muir T, Takase-Sanchez MM, Hale DS, Van Drie D, Varma MG. A vaginal bowel-control system for the treatment of fecal incontinence. Obstet Gynecol. 2015 Mar;125(3):540-7. doi: 10.1097/AOG.0000000000000639. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Endpoint - Number of Device Related Adverse Events	The number of device-related adverse events and device-related serious adverse events (related defined as probably or definitely).; Events are classified as occurring either during fitting (the process of identifying the correct size of the device) or during treatment (defined as the time when a patient receives their long term wear device until the completion of the study).	3, 6, 9 and 12 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   A Vaginal Bowel-Control System for the Treatment of Fecal Incontinence (results of the LIFE Study)