Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia

Anal Fistula Clinical Trial

— SurgiSIS AFP  

Official title:

A Single-center Single Arm Prospective Study Evaluating the Surgisis Biodesign Anal Fistula Plug

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00703131
• Other study ID #: 07-012
• Status: Completed
• Phase: N/A
• First received: June 20, 2008
• Last updated: February 10, 2015
• Start date: April 2009
• Est. completion date: November 2014

Study information

• Verified date: February 2015
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: Saudi Arabia: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Device:
• Anal Fistula Plug (SurgiSIS AFP)
Anal Fistula Plug

Locations

Country	Name	City	State
Saudi Arabia	King Khalid University Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healing Success		12 months	No
Secondary	Change in Quality of Life Measures		3, 6, and 12 months	No