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

Completed

• Conditions: Anal Fistula
• Interventions: Device: reinforce soft tissue

• Registration Number: NCT01602081
• Lead Sponsor: Cook Group Incorporated

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-16
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-18
• Study Start: 2013-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-10
• Last Update Posted: 2015-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LIFT+Biodesign	reinforce soft tissue	-

Primary Outcome Measures

Name	Time	Method
Closure of the anal fistula	6 months

Secondary Outcome Measures

Name	Time	Method
Closure of the anal fistula	12 months

Trial Locations

Locations (8)

Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Indiana University Hospitals; 🇺🇸 Indianapolis, Indiana, United States

University of California Irvine; 🇺🇸 Orange, California, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

Kendrick Regional Center; 🇺🇸 Indianapolis, Indiana, United States

Ochsner Clinic Foundation; 🇺🇸 New Orleans, Louisiana, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States