A Multi-Center, Prospective, Non-Randomized Study of the Renew Insert Efficacy, Safety and Tolerability For the Management of Accidental Bowel Leakage Due to Bowel Incontinence

Status: Completed
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to determine whether the use of the Renew Insert is effective, tolerable and safe in the treatment of accidental bowel leakage due to bowel incontinence.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Signed Informed Consent

• Minimum Wexner Bowel incontinence score of 12 AND at least weekly (score of 3 or higher) leakage of solid and/or liquid type stool, with no greater than 50% of subjects with daily (score 4) of uncontrolled gas.

• Patients colon surveillance must be in compliance with American Cancer Society colon screening guidelines. If patient is out of compliance, they may be scheduled for Colonoscopy.

• Patient comprehends study meaning & is capable of carrying out study duties

• Fluent in English

Locations
United States
California
Dr. Segall
Los Gatos
UCSD Medical Center
San Diego
Florida
Cleveland Clinic Florida
Weston
Time Frame
Start Date: December 2009
Completion Date: December 2011
Participants
Target number of participants: 97
Related Therapeutic Areas
Sponsors
Leads: Renew Medical

This content was sourced from clinicaltrials.gov

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