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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01602081

Acronym

LIFT+Graft

Enrollment

Registered

2012-05-18

Start date

2013-01-31

Completion date

2015-01-31

Last updated

2015-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anal Fistula

Keywords

Anal fistula, Ligation of the intersphincteric fistula tract, LIFT, Tissue graft

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.

Interventions

DEVICEreinforce soft tissue

reinforce soft tissue

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Closure of the anal fistula	6 months

Secondary

Measure	Time frame
Closure of the anal fistula	12 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026