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

Cook Group Incorporated21 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Anal Fistula Crohn's Disease

Interventions

Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)DEVICE

Surgical placement of the Surgisis AFP is performed under general anesthesia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Cedars-Sinai Medical Center

Los Angeles, California, United States

Mount Sinai Medical Center

New York, New York, United States

Univeristy Hospitals Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Fistula Closure (Patient Based)

Fistula closure is defined as absence of drainage at the external fistula opening.

Time frame: 12 months

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.

Time frame: 12 months

Data from ClinicalTrials.gov

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