Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft

Crohn's Disease Clinical Trial

— SurgiSIS AFP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00610207
• Other study ID #: 06-002
• Status: Terminated
• Phase: N/A
• First received: January 24, 2008
• Last updated: December 29, 2015
• Start date: March 2007
• Est. completion date: April 2010

Study information

• Verified date: March 2012
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: April 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anal Fistula
• Crohn Disease
• Crohn's Disease
• Fistula

Intervention

Device:
• Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)
Surgical placement of the Surgisis AFP is performed under general anesthesia

Locations

Country	Name	City	State
United States	Univeristy Hospitals Medical Center	Cleveland	Ohio
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Mount Sinai Medical Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Cook	Cook Biotech Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fistula Closure (Patient Based)	Fistula closure is defined as absence of drainage at the external fistula opening.	12 months	No
Primary	Fistula Closure (Tract Based)	Fistula closure is defined as absence of drainage at the external fistula opening.; An anorectal fistula is an inflammatory tract or connection between the epithelialized surface of the anal canal and most frequently, the perianal skin or perineum. It is possible to have multiple fistula tracts present on a patient.	12 months	No