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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.)
Sponsor:
Collaborator:
Cook Biotech Incorporated
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT00610207
First received: January 24, 2008
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  Purpose

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: Allocation: Non-Randomized
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:

U.S. FDA Resources

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.

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00610207

Locations
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
Cook Biotech Incorporated
Investigators
Principal Investigator: Beth Moore, MD Colon & Rectal Surgeons of Southern California, Mt. Sinai
  More Information

No publications provided

Responsible Party: Cook
ClinicalTrials.gov 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: March 6, 2012
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
Fistula
Rectal Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
 Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Rectal Diseases

ClinicalTrials.gov processed this record on May 23, 2013