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

Case Medical Center

Cleveland, Ohio 44106

2036

from 91732

Cleveland, OH