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OpenTrials
Completed

NCT Number: NCT01602081

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

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.

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Key information

Conditions

Anal Fistula Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California Irvine, Orange, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

reinforce soft tissue

Device

reinforce soft tissue

Primary outcomes

  1. Closure of the anal fistula

    Time frame: 6 months

Secondary outcomes

  1. Closure of the anal fistula

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

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

Acronym: LIFT+Graft

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
May 18, 2012
Registry last updated
Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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