Skip to main content
OpenTrials
Completed

NCT Number: NCT02428595

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Fecal Incontinence Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama, Birmingham, Alabama, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Eclipse™ System

Device

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 names: Vaginal Bowel Control (VBC) Therapy

Primary outcomes

  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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Pelvalon, Inc.

Industry

Registry information

Acronym: LIBERATE

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2015
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.