Status:
COMPLETED
A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage
Lead Sponsor:
Renew Medical
Conditions:
Bowel Incontinence
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed Description
Prospective, open label, single-arm, non-randomized, multi-center study designed to evaluate the efficacy, safety and tolerability of the Renew Insert in moderate-to-severe bowel incontinence patients...
Eligibility Criteria
Inclusion
- 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
Exclusion
- American Society of Anesthesiologist (ASA) score of 4 or higher
- Spinal cord injury or other major neurological diagnosis
- Known immune deficiency state
- Significant cardiac arrhythmia
- Pregnant or Breastfeeding
- Inflammatory bowel disease
- Requirement of medication delivered by suppository
- Active perianal abscess or fistula
- Present rectal prolapse
- Third degree hemorrhoids
- Anal stricture
- History or rectal spasm
- Rectal surgery in past 6 months
- Unresolved Anismus
- Fecal impaction with overflow diarrhea
- Ileo-anal pouch
- Rectocele requiring surgery
- Allergy to silicone or one of its components
- Significant medical condition which interferes with study participation
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01475474
Start Date
December 1 2009
End Date
December 1 2011
Last Update
November 28 2013
Active Locations (3)
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1
Dr. Segall
Los Gatos, California, United States, 95032
2
UCSD Medical Center
San Diego, California, United States, 92103-8897
3
Cleveland Clinic Florida
Weston, Florida, United States, 33331