Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia
Launched by COOK GROUP INCORPORATED · Jun 20, 2008
Trial Information
Current as of May 19, 2025
Completed
Keywords
ClinConnect Summary
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 follow-up.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Cook Group Incorporated
Cook Group Incorporated is a globally recognized leader in the medical device industry, dedicated to advancing healthcare through innovative technology and research. With a strong commitment to improving patient outcomes, Cook Group specializes in a diverse range of products, including vascular, urological, and gastrointestinal devices. The company actively sponsors clinical trials to evaluate the safety and efficacy of its innovative solutions, ensuring they meet the highest standards of quality and effectiveness. Through collaboration with healthcare professionals and institutions, Cook Group aims to drive medical advancements and enhance the standard of care in various therapeutic areas.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Riyadh, , Saudi Arabia
Patients applied
Trial Officials
Ahmad Zubaidi, MD
Principal Investigator
King Khalid University Hospital
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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