Clinical Trial: A Clinical Evaluation of a Vaginal Bowel Control System for the Treatment of Fecal Incontinence in Women (LIFE)

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Clinical Evaluation of the LivSure Vaginal Bowel Control (VBC) System for the Treatment of Fecal Incontinence in Women.

Brief Summary: The objective of this study is to obtain preliminary efficacy and safety data on the use of the LivSure System (now called the "Eclipse™ System") in women with fecal incontinence.

Detailed Summary:
Sponsor: Pelvalon, Inc.

Current Primary Outcome: Frequency of FI Episodes [ Time Frame: 1 Month ]

Subjects with at least a 50% reduction in FI episodes (major or minor soiling)


Original Primary Outcome:

Current Secondary Outcome:

  • Number of Incontinent Days [ Time Frame: 1 Month ]
    Change in number of incontinent days while wearing the device during the 2-week assessment period as compared to the baseline 2-week assessment period
  • Device-related Adverse Events [ Time Frame: 1month ]
    The number of overall adverse events rated as probably or definitely related to the study device.


Original Secondary Outcome:

Information By: Pelvalon, Inc.

Dates:
Date Received: July 24, 2012
Date Started: August 2012
Date Completion:
Last Updated: May 22, 2015
Last Verified: May 2015