Study Stopped
Study stopped early due to staffing changes at the site.
Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft
SurgiSIS AFP
1 other identifier
interventional
21
1 country
3
Brief Summary
Healing anal fistulas in Crohn's patients with an anal fistula plug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2007
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
January 24, 2008
CompletedFirst Posted
Study publicly available on registry
February 7, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedResults Posted
Study results publicly available
August 17, 2011
CompletedFebruary 2, 2016
March 1, 2012
3.1 years
January 24, 2008
April 25, 2011
December 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Fistula Closure (Patient Based)
Fistula closure is defined as absence of drainage at the external fistula opening.
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.
12 months
Study Arms (1)
AFP
EXPERIMENTALAnal fistula plug placement performed during surgical procedure
Interventions
Surgical placement of the Surgisis AFP is performed under general anesthesia
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patient is pregnant or lactating
- Patient has peri-anal drainage with originates from outside the anorectal tract
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cook Group Incorporatedlead
- Cook Biotech Incorporatedcollaborator
Study Sites (3)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Univeristy Hospitals Medical Center
Cleveland, Ohio, 44106, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Early termination did lead to small patient numbers.
Results Point of Contact
- Title
- Jason Hodde, Clinical Affairs Manager
- Organization
- Cook Biotech, Incorporated
Study Officials
- PRINCIPAL INVESTIGATOR
Beth Moore, MD
Colon & Rectal Surgeons of Southern California, Mt. Sinai
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2008
First Posted
February 7, 2008
Study Start
March 1, 2007
Primary Completion
April 1, 2010
Study Completion
April 1, 2010
Last Updated
February 2, 2016
Results First Posted
August 17, 2011
Record last verified: 2012-03