Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia (SurgiSIS AFP)

Cook Group

Status: Completed

Conditions: Anal Fistula

Treatments: Device: Anal Fistula Plug (SurgiSIS AFP)

Study type: Observational

Funder types: Industry

Identifiers

NCT00703131

07-012

Details and patient eligibility

About

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.

Full 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 follow-up.

Enrollment: 35 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

35 participants in 1 patient group

1

Description:

Anal Fistula Plug

Treatment:

Device: Anal Fistula Plug (SurgiSIS AFP)