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

Status:	Completed
Conditions:	Hospital, Gastrointestinal
Therapuetic Areas:	Gastroenterology, Other
Healthy:	No
Age Range:	18 - Any
Updated:	3/1/2014
Start Date:	January 2013
End Date:	January 2015
Contact:	Brenda Johnson
Email:	bmjohnson@medinst.com
Phone:	765-463-7537

Ligation of the Intersphincteric Fistula Tract With Tissue Graft Placement for Treatment of Persistent Trans-sphincteric 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 graft as part of their LIFT procedure.

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

We found this trial at

sites

Hospital of the University of Pennsylvania

3400 Spruce St
Philadelphia, Pennsylvania 19104

(215) 662-4000