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

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. Identifier: NCT02428595
Recruitment Status : Completed
First Posted : April 29, 2015
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Information provided by (Responsible Party):
Pelvalon, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Fecal Incontinence Device: Eclipse™ System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 137 participants
Allocation: N/A
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
Actual Study Start Date : May 15, 2015
Actual Primary Completion Date : July 18, 2018
Actual Study Completion Date : July 18, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

Other Outcome Measures:
  1. 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).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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 identifier (NCT number): NCT02428595

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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.
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Principal Investigator: Holly Richter, PhD, MD University of Alabama at Birmingham
  Study Documents (Full-Text)

Documents provided by Pelvalon, Inc.:
Study Protocol  [PDF] February 9, 2017
Statistical Analysis Plan  [PDF] April 2, 2018

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Pelvalon, Inc. Identifier: NCT02428595    
Other Study ID Numbers: CA005
First Posted: April 29, 2015    Key Record Dates
Results First Posted: September 24, 2019
Last Update Posted: September 24, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Fecal Incontinence
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases