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COMPLETEDNCT01602081

Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula

The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graf...

Lead sponsor: Cook Group Incorporated•8 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Cook Group Incorporated

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Persistent primary or recurrent trans-sphincteric anal fistula

Exclusion Criteria

•Patients with prior fistulotomy, fistulectomy, LIFT, cutting seton or advancement flap procedure
•Fistula with multiple tracts
•Recto-vaginal fistula
•Active infection in the anal fistula
•Physical allergies or cultural objections to porcine products
•Patient is not medically fit to undergo the LIFT procedure as judged by the treating physician
•Previous diagnosis of collagen disorder
•History of Crohn's Disease, Irritable Bowel Syndrome, radiation therapy in the rectoanal region

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: February 11, 2015Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment28

Start dateJan 2013

Last updatedFeb 11, 2015

Condition

Locations shown

University of California Irvine

Orange, California

Rush University Medical Center

Chicago, Illinois

Indiana University Hospitals

Indianapolis, Indiana

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2015Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions