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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01602081
Recruitment Status : Completed
First Posted : May 18, 2012
Last Update Posted : February 11, 2015
Information provided by (Responsible Party):
Cook Group Incorporated

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.

Condition or disease Intervention/treatment
Anal Fistula Device: reinforce soft tissue

Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ligation of the Intersphincteric Fistula Tract With Tissue Graft Placement for Treatment of Persistent Trans-sphincteric Anal Fistula
Study Start Date : January 2013
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Group/Cohort Intervention/treatment
LIFT+Biodesign Device: reinforce soft tissue
reinforce soft tissue

Primary Outcome Measures :
  1. Closure of the anal fistula [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Closure of the anal fistula [ Time Frame: 12 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Regional and Community Hospitals

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01602081

United States, California
University of California Irvine
Orange, California, United States, 92868
United States, Illinois
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University Hospitals
Indianapolis, Indiana, United States, 46202
Kendrick Regional Center
Indianapolis, Indiana, United States, 46237
United States, Louisiana
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
United States, New York
Mount Sinai Hospital
New York, New York, United States, 10021
United States, Ohio
Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19106
Sponsors and Collaborators
Cook Group Incorporated

Responsible Party: Cook Group Incorporated Identifier: NCT01602081     History of Changes
Other Study ID Numbers: 10-012
First Posted: May 18, 2012    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015

Keywords provided by Cook Group Incorporated:
Anal fistula
Ligation of the intersphincteric fistula tract
Tissue graft

Additional relevant MeSH terms:
Rectal Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases