Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft

Not Applicable

Terminated

• Conditions: Crohn's Disease; Anal Fistula
• Interventions: Device: Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)

• Registration Number: NCT00610207
• Lead Sponsor: Cook Group Incorporated

Brief Summary

Healing anal fistulas in Crohn's patients with an anal fistula plug.

Detailed Description

The purpose of this study is to determine whether the Surgisis anal fistula plug is effective in healing anal fistulas in patients diagnosed with Crohn's Disease.

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2008-01-24
• Study First Submitted QC: 2008-02-06
• Study First Posted: 2008-02-07
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Results First Submitted: 2011-04-25
• Results First Submitted QC: 2011-07-21
• Results First Posted: 2011-08-17
• Status Verified: 2012-03
• Last Update Submitted: 2015-12-29
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• Patient is diagnosed with Crohn's Disease
• Patient has a chronically draining anal fistula of Crohn's origin
• Patient is 18 years old or older
• Patient has signed an informed consent

Exclusion Criteria

• Patient is pregnant or lactating
• Patient has peri-anal drainage with originates from outside the anorectal tract

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AFP	Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)	Anal fistula plug placement performed during surgical procedure

Primary Outcome Measures

Name	Time	Method
Fistula Closure (Patient Based)	12 months	Fistula closure is defined as absence of drainage at the external fistula opening.
Fistula Closure (Tract Based)	12 months	Fistula closure is defined as absence of drainage at the external fistula opening.; An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient.

Trial Locations

Locations (3)

Cedars-Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Mount Sinai Medical Center; 🇺🇸 New York, New York, United States

Univeristy Hospitals Medical Center; 🇺🇸 Cleveland, Ohio, United States