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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01602081
First received: May 16, 2012
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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 Intervention
Anal Fistula
Device: reinforce soft tissue

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Cook:

Primary Outcome Measures:
  • Closure of the anal fistula [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Closure of the anal fistula [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
LIFT+Biodesign Device: reinforce soft tissue
reinforce soft tissue

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Regional and Community Hospitals

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01602081

Locations
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
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov Identifier: NCT01602081     History of Changes
Other Study ID Numbers: 10-012
Study First Received: May 16, 2012
Last Updated: February 12, 2014
Health Authority: None: No oversight authorities for this observational data collection gathering information on indication with an approved device.

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

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

ClinicalTrials.gov processed this record on October 19, 2014