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A Study to Evaluate the Safety, Tolerability and Effectiveness of the Renew Insert in Treating Accidental Bowel Leakage

NCT01475474 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2013-11-28

Study results available
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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.

Conditions

  • Bowel Incontinence

Interventions

DEVICE

Renew Insert

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.

Sponsors & Collaborators

  • Renew Medical

    lead INDUSTRY

Principal Investigators

  • Steven D Wexner, MD · Cleveland Clinic Florida

  • Emily Lukacz, MD · University of California, San Diego, CA

  • Mark Segall, MD · The medical office of Mark Segall MD

  • Eric G Weiss, MD · Cleveland Clinic Florida

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-11-30
Completion
2011-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01475474 on ClinicalTrials.gov