CClinicalTrials.gg
CompletedNCT01602081LIFT+GraftUpdated Feb 11, 2015

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

An observational study in Anal Fistula, sponsored by Cook Group Incorporated. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-11.

Sponsored by Cook Group Incorporated · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
28
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anal Fistula

Keywords

  • Anal fistula
  • Ligation of the intersphincteric fistula tract
  • LIFT
  • Tissue graft
03

In context

Rectal Fistula

189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.

This study's enrollment of 28 is below the median of 94 across 50 observational studies indexed under Rectal Fistula.

Browse Rectal Fistula studies →

Lead sponsor

Cook Group Incorporated is the lead sponsor of 73 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
28 participants (actual)

Groups and cohorts

  • LIFT+Biodesign

    Device: reinforce soft tissue

Interventions

  • Devicereinforce soft tissue

    reinforce soft tissue

06

What researchers measure

Primary outcomes

  1. Closure of the anal fistula

    Time frame: 6 months

Secondary outcomes

  1. Closure of the anal fistula

    Time frame: 12 months

07

Study locations

8 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01602081
Lead sponsor
Cook Group Incorporated
Responsible party
Sponsor
First posted
May 18, 2012
Start date
Jan 2013
Primary completion
Jan 2015
Completion
Jan 2015
Last update
Feb 11, 2015
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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