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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:
ClinicalTrials.gov Identifier:
NCT00610207
First Posted: February 7, 2008
Last Update Posted: February 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Cook Biotech Incorporated
Information provided by (Responsible Party):
Cook Group Incorporated
  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: Intervention Model: Single Group Assignment
Masking: None (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 Group Incorporated:

Primary Outcome Measures:
  • Fistula Closure (Patient Based) [ Time Frame: 12 months ]
    Fistula closure is defined as absence of drainage at the external fistula opening.

  • Fistula Closure (Tract Based) [ Time Frame: 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.



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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Group Incorporated
Cook Biotech Incorporated
Investigators
Principal Investigator: Beth Moore, MD Colon & Rectal Surgeons of Southern California, Mt. Sinai
  More Information

Responsible Party: Cook Group Incorporated
ClinicalTrials.gov Identifier: NCT00610207     History of Changes
Other Study ID Numbers: 06-002
First Submitted: January 24, 2008
First Posted: February 7, 2008
Results First Submitted: April 25, 2011
Results First Posted: August 17, 2011
Last Update Posted: February 2, 2016
Last Verified: March 2012

Keywords provided by Cook Group Incorporated:
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