Anal Fistula
Conditions
Keywords
fistula, anal fistula
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 follow-up.
Interventions
DEVICEAnal Fistula Plug (SurgiSIS AFP)
Anal Fistula Plug
Sponsors
Cook Group Incorporated
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing Success | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Change in Quality of Life Measures | 3, 6, and 12 months |
Countries
Saudi Arabia
Outcome results
None listed