A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage
Completed · Not applicable
Conditions studied: Bowel Incontinence
In brief
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.
Key facts
- Study ID
- NCT01475474
- Run by
- Renew Medical
- People needed
- 97
- Starts
- 2009-12-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2013-11-28
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Dr. Segall — Los Gatos, California, United States
- UCSD Medical Center — San Diego, California, United States
- Cleveland Clinic Florida — Weston, Florida, United States
Full record on ClinicalTrials.gov
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