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

NCT ID: NCT01602081

Last Updated: 2015-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

28 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Anal Fistula

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LIFT+Biodesign

reinforce soft tissue

Intervention Type DEVICE

reinforce soft tissue

Interventions

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reinforce soft tissue

reinforce soft tissue

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cook Group Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of California Irvine

Orange, California, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Indiana University Hospitals

Indianapolis, Indiana, United States

Site Status

Kendrick Regional Center

Indianapolis, Indiana, United States

Site Status

Ochsner Clinic Foundation

New Orleans, Louisiana, United States

Site Status

Mount Sinai Hospital

New York, New York, United States

Site Status

Case Medical Center

Cleveland, Ohio, United States

Site Status

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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10-012

Identifier Type: -

Identifier Source: org_study_id

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