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A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women (LIBERATE)
This study is ongoing, but not recruiting participants.
Sponsor:
Pelvalon, Inc.
Information provided by (Responsible Party):
Pelvalon, Inc.
ClinicalTrials.gov Identifier:
NCT02428595
First received: April 18, 2015
Last updated: February 16, 2017
Last verified: February 2017
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Purpose
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.
| Condition | Intervention |
|---|---|
| Fecal Incontinence | Device: Eclipse™ System |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment |
| Official Title: | A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women |
Resource links provided by NLM:
Further study details as provided by Pelvalon, Inc.:
Primary Outcome Measures:
- Proportion of treatment Responders in the Intent to Treat (ITT) cohort [ Time Frame: 3 months ]% reduction in the average number of FI episodes per week
Secondary Outcome Measures:
- Proportion of treatment responders in the Per Protocol (PP) population [ Time Frame: 3, 6 and 12 months ]% reduction in the average number of FI episodes per week
- Change in mean scores on subject-reported outcomes related to symptom severity [ Time Frame: 3, 6 and 12 months ]St. Mark's (Vaizey) Incontinence Severity Score
- Patient Global Impression of Improvement (PGI-I) scores [ Time Frame: 3, 6, 9 and 12 months ]
- Change in mean scores on subject-reported outcomes related to QoL [ Time Frame: 3, 6 and 12 months ]Fecal Incontinence QoL (FIQoL)
Other Outcome Measures:
- Safety Endpoint [ Time Frame: 3, 6, 9 and 12 months ]The number of device-related adverse events, and device-related serious adverse events
| Estimated Enrollment: | 75 |
| Study Start Date: | May 2015 |
| Estimated Study Completion Date: | June 2018 |
| Estimated Primary Completion Date: | September 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment
Eclipse™ System
|
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
|
Eligibility| Ages Eligible for Study: | 19 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Abbreviated Inclusion Criteria:
- History of 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 FI 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02428595
Please refer to this study by its ClinicalTrials.gov identifier: NCT02428595
Locations
| 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 | |
| Christ Hospital | |
| 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 Methodist | |
| 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 | |
Sponsors and Collaborators
Pelvalon, Inc.
Investigators
| Principal Investigator: | Holly Richter, PhD, MD | University of Alabama at Birmingham |
More Information
Additional Information:
Publications:
| Responsible Party: | Pelvalon, Inc. |
| ClinicalTrials.gov Identifier: | NCT02428595 History of Changes |
| Other Study ID Numbers: |
CA005 |
| Study First Received: | April 18, 2015 |
| Last Updated: | February 16, 2017 |
Additional relevant MeSH terms:
|
Fecal Incontinence Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on June 28, 2017