A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women (LIBERATE)
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|ClinicalTrials.gov Identifier: NCT02428595|
Recruitment Status : Completed
First Posted : April 29, 2015
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Device: Eclipse™ System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||137 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women|
|Actual Study Start Date :||May 15, 2015|
|Actual Primary Completion Date :||July 18, 2018|
|Actual Study Completion Date :||July 18, 2018|
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.
Other Name: Vaginal Bowel Control (VBC) Therapy
- Count of Treatment Responders in the Intent to Treat (ITT) Cohort [ Time Frame: 3 months ]Count of patients with >50% reduction in the average number of FI episodes per week as compared to baseline.
- Count of Treatment Responders in the Per Protocol (PP) Population [ Time Frame: 3, 6 and 12 months ]Count of patients with >50% reduction in the average number of FI episodes per week as compared to Baseline.
- Change in St. Mark's (Vaizey) Incontinence Severity Score as Compared to Baseline [ Time Frame: 12 months ]
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.
- Change in Fecal Incontinence Quality of Life (FIQoL) Score as Compared to Baseline [ Time Frame: 12 months ]
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.
- Numbers of Participants With Specific Patient Global Impression of Improvement (PGI-I) Scores [ Time Frame: 3, 6, 9 and 12 months ]
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.
- Safety Endpoint - Number of Device Related Adverse Events [ Time Frame: 3, 6, 9 and 12 months ]
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02428595
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35233|
|United States, Massachusetts|
|Massachusetts General Hospital (MGH)|
|Boston, Massachusetts, United States, 02114|
|United States, New Mexico|
|University of New Mexico|
|Albuquerque, New Mexico, United States, 87131|
|United States, North Carolina|
|University of North Carolina|
|Raleigh, North Carolina, United States, 27607|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45219|
|United States, Oklahoma|
|University of Oklahoma|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Rhode Island|
|Brown University (WIHRI)|
|Providence, Rhode Island, United States, 02903|
|United States, Texas|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Providence Sacred Heart|
|Spokane, Washington, United States, 99204|
|United States, Wisconsin|
|University of Wisconsin|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Holly Richter, PhD, MD||University of Alabama at Birmingham|