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

Completed

Conditions studied: Anal Fistula

In brief

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 graft as part of their LIFT procedure.

Key facts

Study ID

NCT01602081

Run by

Cook Group Incorporated

People needed

28

Starts

2013-01-01

Expected to finish

2015-01-01

Last updated by the study team

2015-02-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Persistent primary or recurrent trans-sphincteric anal fistula

You may not qualify if…

• 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

Where it is running

• University of California Irvine — Orange, California, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Indiana University Hospitals — Indianapolis, Indiana, United States
• Kendrick Regional Center — Indianapolis, Indiana, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Mount Sinai Hospital — New York, New York, United States
• Case Medical Center — Cleveland, Ohio, United States
• Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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