Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft (SurgiSIS AFP)

This study has been terminated.
(Study stopped early due to staffing changes at the site.)
Cook Biotech Incorporated
Information provided by (Responsible Party):
Cook Identifier:
First received: January 24, 2008
Last updated: December 29, 2015
Last verified: March 2012
Healing anal fistulas in Crohn's patients with an anal fistula plug.

Condition Intervention
Anal Fistula
Crohn's Disease
Device: Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft (SurgiSIS AFP)

Resource links provided by NLM:

Further study details as provided by Cook:

Primary Outcome Measures:
  • Fistula Closure (Patient Based) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Fistula closure is defined as absence of drainage at the external fistula opening.

  • Fistula Closure (Tract Based) [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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.

Enrollment: 21
Study Start Date: March 2007
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AFP
Anal fistula plug placement performed during surgical procedure
Device: Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)
Surgical placement of the Surgisis AFP is performed under general anesthesia
Other Name: SurgiSIS Biodesign

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00610207

United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, New York
Mount Sinai Medical Center
New York, New York, United States, 10029
United States, Ohio
Univeristy Hospitals Medical Center
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
Cook Biotech Incorporated
Principal Investigator: Beth Moore, MD Colon & Rectal Surgeons of Southern California, Mt. Sinai
  More Information

Responsible Party: Cook Identifier: NCT00610207     History of Changes
Other Study ID Numbers: 06-002 
Study First Received: January 24, 2008
Results First Received: April 25, 2011
Last Updated: December 29, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Cook:
Anal fistula
fistula in ano
anorectal fistula
Crohn's Disease

Additional relevant MeSH terms:
Crohn Disease
Digestive System Diseases
Gastrointestinal Diseases
Inflammatory Bowel Diseases
Intestinal Diseases
Pathological Conditions, Anatomical processed this record on April 27, 2016