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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:
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
History of Changes
April 18, 2015
February 16, 2017
May 2015
September 2017   (Final data collection date for primary outcome measure)
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
Not Provided
Complete list of historical versions of study NCT02428595 on ClinicalTrials.gov Archive Site
  • 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)
Not Provided
Safety Endpoint [ Time Frame: 3, 6, 9 and 12 months ]
The number of device-related adverse events, and device-related serious adverse events
Not Provided
 
A Clinical Evaluation of the Eclipse™ System, a Vaginal Bowel Control (VBC) Therapy for Fecal Incontinence in Women
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.
Not Provided
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Fecal Incontinence
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
Experimental: Treatment
Eclipse™ System
Intervention: Device: Eclipse™ System
Richter HE, Matthews CA, Muir T, Takase-Sanchez MM, Hale DS, Van Drie D, Varma MG. A vaginal bowel-control system for the treatment of fecal incontinence. Obstet Gynecol. 2015 Mar;125(3):540-7. doi: 10.1097/AOG.0000000000000639.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
75
June 2018
September 2017   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
19 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02428595
CA005
No
Not Provided
Not Provided
Pelvalon, Inc.
Pelvalon, Inc.
Not Provided
Principal Investigator: Holly Richter, PhD, MD University of Alabama at Birmingham
Pelvalon, Inc.
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP