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 ]
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