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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:
ClinicalTrials.gov Identifier:
NCT02428595
First Posted: April 29, 2015
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pelvalon, Inc.
  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: None (Open Label)
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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

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


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
First Submitted: April 18, 2015
First Posted: April 29, 2015
Last Update Posted: February 20, 2017
Last Verified: February 2017

Additional relevant MeSH terms:
Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases