Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft (Surgisis AFP) - Full Text View

Sponsors and Collaborators:	Cook Cook Biotech Incorporated
Information provided by:	Cook
ClinicalTrials.gov Identifier:	NCT00610207

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)

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Fistulas

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment
Official Title:	Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft (Surgisis AFP)

Further study details as provided by Cook:

Primary Outcome Measures:

Healing [ Time Frame: 12 weeks with 6 mo and 12 mo follow ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Fecal Incontinence Score Change [ Time Frame: 12 weeks with 6 mo and 12 mo follow ups ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2006
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
AFP: Experimental 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

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

Contacts

Contact: Jason Hodde	765-497-3355 ext 4929	jhodde@CookBiotech.com
Contact: David Hucks	765-497-3355	dhucks@cookbiotech.com

Locations

United States, California
Cedars-Sinai Medical Center	Completed
Los Angeles, California, United States, 90048
United States, New York
Mount Sinai Medical Center	Recruiting
New York, New York, United States, 10029
Contact: Alex Ky, MD 212-241-3547 alex.ky@mountsinai.org
Contact: Erin Ly 212-241-3547 erin.ly@msnyuhealth.org
United States, Ohio
Univeristy Hospitals Medical Center	Recruiting
Cleveland, Ohio, United States, 44106
Contact: Bridget Ermlich, RN 216-844-3602 bridget.ermlich@UHhospitals.org
Contact: Brad Champagne, MD 216-844-3602

Sponsors and Collaborators

Cook

Cook Biotech Incorporated

Investigators

Principal Investigator:

Beth Moore, MD

Colon & Rectal Surgeons of Southern California, Mt. Sinai

More Information

Responsible Party:	Cook Biotech Incorporated ( Jason Hodde, Clinical Affairs Manager )
Study ID Numbers:	06-002
Study First Received:	January 24, 2008
Last Updated:	December 2, 2008
ClinicalTrials.gov Identifier:	NCT00610207
Health Authority:	United States: Institutional Review Board

Keywords provided by Cook:

Anal fistula
fistula in ano
anorectal fistula
Crohn's Disease

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Rectal Fistula
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Fistula
Crohn Disease

Inflammatory Bowel Diseases
Gastroenteritis
Intestinal Diseases
Rectal Diseases
Fistula

Additional relevant MeSH terms:

Digestive System Fistula

ClinicalTrials.gov processed this record on January 15, 2009