Status:
TERMINATED
Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft
Lead Sponsor:
Cook Group Incorporated
Collaborating Sponsors:
Cook Biotech Incorporated
Conditions:
Anal Fistula
Crohn's Disease
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- Patient is pregnant or lactating
- Patient has peri-anal drainage with originates from outside the anorectal tract
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00610207
Start Date
March 1 2007
End Date
April 1 2010
Last Update
February 2 2016
Active Locations (3)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
Mount Sinai Medical Center
New York, New York, United States, 10029
3
Univeristy Hospitals Medical Center
Cleveland, Ohio, United States, 44106