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

Cook Group

Status: Completed

Conditions: Anal Fistula

Treatments: Device: reinforce soft tissue

Study type: Observational

Funder types: Industry

Identifiers

NCT01602081

10-012

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

28 participants in 1 patient group

LIFT+Biodesign

Treatment:

Device: reinforce soft tissue