Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft (SurgiSIS AFP)

Cook Group

Status: Terminated

Conditions: Anal Fistula; Crohn's Disease

Treatments: Device: Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00610207

06-002

Details and patient eligibility

About

Healing anal fistulas in Crohn's patients with an anal fistula plug.

Full description

The purpose of this study is to determine whether the Surgisis anal fistula plug is effective in healing anal fistulas in patients diagnosed with Crohn's Disease.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient is diagnosed with Crohn's Disease
• Patient has a chronically draining anal fistula of Crohn's origin
• Patient is 18 years old or older
• Patient has signed an informed consent

Exclusion criteria

• Patient is pregnant or lactating
• Patient has peri-anal drainage with originates from outside the anorectal tract

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

AFP

Experimental group

Description:

Anal fistula plug placement performed during surgical procedure

Treatment:

Device: Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)