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

Anal Fistula Clinical Trial

— LIFT+Graft  

Official title:

Ligation of the Intersphincteric Fistula Tract With Tissue Graft Placement for Treatment of Persistent Trans-sphincteric Anal Fistula

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01602081
• Other study ID #: 10-012
• Status: Completed
• Phase: N/A
• First received: May 16, 2012
• Last updated: February 10, 2015
• Start date: January 2013
• Est. completion date: January 2015

Study information

• Verified date: February 2015
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: None: No oversight authorities for this observational data collection gathering information on indication with an approved device.
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Device:
• reinforce soft tissue
reinforce soft tissue

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois
United States	Case Medical Center	Cleveland	Ohio
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	University of California Irvine	Orange	California
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Closure of the anal fistula		6 months	No
Secondary	Closure of the anal fistula		12 months	No