At a glance
ClinicalIndex Comparison RecordN/ACompleted· 97 enrolled
Drug / intervention
Renew Insertdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A clinical study evaluating Renew Insert for Bowel Incontinence. Completed, enrolled 97 participants across 3 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBowel Incontinence
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
Primary CompletionNov 2011
First PostedNov 2011
Study CompletionDec 2011
TodayJul 2026
First PostedNov 21, 2011
Enrollment StartDec 1, 2009
Primary CompletionNov 1, 2011
Study CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.6 years ago
Interventions
Renew Insertdevice
The Renew Insert is indicated for the management of accidental bowel leakage due to bowel incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.