Status:
COMPLETED
Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia
Lead Sponsor:
Cook Group Incorporated
Conditions:
Anal Fistula
Eligibility:
All Genders
Brief Summary
The Surgisis Anal Fistula Plug study is a clinical trial conducted in Saudi Arabia to study the safety and effectiveness of the Surgisis AFP Plug in the treatment of chronic anal fistulas.
Detailed Description
Up to 30 patients will be treated with the Surgisis Anal Fistula Plug using a standardized surgical procedure to plug their anal fistula. Patients will be followed periodically until their 12-month fo...
Eligibility Criteria
Inclusion
- 18 years old or older
- Primary, persistent, or recurrent fistula tract that is either transsphincteric, suprasphincteric, or extrasphincteric
- Signed informed consent
- Willing to return for follow-up visits
Exclusion
- Crohn's Disease
- Ulcerative Colitis
- HIV Positive
- Immune System Disorder
- Collagen Disorder
- Tuberculosis
- History of radiation to anorectal region
- Allergies to pig tissue
- Religious or cultural objection to use of pig tissue in this surgical application
- J-pouch fistulas
- Previous Surgisis AFP Plug placement in target fistula tract
- Tracts with acute abscess, infection or inflammation
- Superficial fistula tracts conventionally treated with fistulotomy/fistulectomy
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00703131
Start Date
April 1 2009
End Date
November 1 2014
Last Update
February 11 2015
Active Locations (1)
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1
King Khalid University Hospital
Riyadh, Saudi Arabia, 11472