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

Primary Purpose

Anal Fistula, Crohn's Disease

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)
Sponsored by
Cook Group Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anal Fistula focused on measuring Anal fistula, fistula in ano, anorectal fistula, Crohn's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cedars-Sinai Medical Center
  • Mount Sinai Medical Center
  • Univeristy Hospitals Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AFP

Arm Description

Anal fistula plug placement performed during surgical procedure

Outcomes

Primary Outcome Measures

Fistula Closure (Patient Based)
Fistula closure is defined as absence of drainage at the external fistula opening.
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.

Secondary Outcome Measures

Full Information

First Posted
January 24, 2008
Last Updated
December 29, 2015
Sponsor
Cook Group Incorporated
Collaborators
Cook Biotech Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT00610207
Brief Title
Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft
Acronym
SurgiSIS AFP
Official Title
Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft (SurgiSIS AFP)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Study stopped early due to staffing changes at the site.
Study Start Date
March 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cook Group Incorporated
Collaborators
Cook Biotech Incorporated

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula, Crohn's Disease
Keywords
Anal fistula, fistula in ano, anorectal fistula, Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AFP
Arm Type
Experimental
Arm Description
Anal fistula plug placement performed during surgical procedure
Intervention Type
Device
Intervention Name(s)
Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP)
Other Intervention Name(s)
SurgiSIS Biodesign
Intervention Description
Surgical placement of the Surgisis AFP is performed under general anesthesia
Primary Outcome Measure Information:
Title
Fistula Closure (Patient Based)
Description
Fistula closure is defined as absence of drainage at the external fistula opening.
Time Frame
12 months
Title
Fistula Closure (Tract Based)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Beth Moore, MD
Organizational Affiliation
Colon & Rectal Surgeons of Southern California, Mt. Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Univeristy Hospitals Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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