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Comparison of the Efficacy of a Biological Implant to Reinforce Overlapping Sphincter Repair Versus Overlapping Sphincter Repair Alone

NCT01044589 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2017-08-01

Study results available
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Summary

The aim of this study is to compare the efficacy of Biodesign™ Surgisis® Tissue Graft to reinforce an overlapping sphincter repair versus the standard overlapping sphincter repair in controlling episodes of incontinence in patients who have fecal incontinence and a defect in the anal sphincter.

Conditions

  • Fecal Incontinence
  • Anal Incontinence

Interventions

DEVICE

Biodesign Tissue Repair Graft

Biodesign Tissue Repair Graft reinforcement

OTHER

Overlapping Sphincter Repair

Overlapping Sphincter Repair Alone

Sponsors & Collaborators

  • Cook Group Incorporated

    collaborator INDUSTRY

  • Massarat Zutshi

    lead OTHER

Principal Investigators

  • Massarat Zutshi, MD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT01044589 on ClinicalTrials.gov