Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula
LIFT+Graft
1 other identifier
observational
28
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2013
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 16, 2012
CompletedFirst Posted
Study publicly available on registry
May 18, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedFebruary 11, 2015
February 1, 2015
2 years
May 16, 2012
February 10, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Closure of the anal fistula
6 months
Secondary Outcomes (1)
Closure of the anal fistula
12 months
Study Arms (1)
LIFT+Biodesign
Interventions
Eligibility Criteria
Regional and Community Hospitals
You may qualify if:
- Persistent primary or recurrent trans-sphincteric anal fistula
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
University of California Irvine
Orange, California, 92868, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Indiana University Hospitals
Indianapolis, Indiana, 46202, United States
Kendrick Regional Center
Indianapolis, Indiana, 46237, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121, United States
Mount Sinai Hospital
New York, New York, 10021, United States
Case Medical Center
Cleveland, Ohio, 44106, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2012
First Posted
May 18, 2012
Study Start
January 1, 2013
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
February 11, 2015
Record last verified: 2015-02