Ligation of the Intersphincteric Fistula Tract (LIFT) + Biodesign for Anal Fistula (LIFT+Graft)
This study is currently recruiting participants.
Verified April 2013 by Cook
Sponsor:
Cook
Information provided by (Responsible Party):
Cook
ClinicalTrials.gov Identifier:
NCT01602081
First received: May 16, 2012
Last updated: April 3, 2013
Last verified: April 2013
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Purpose
The LIFT+Biodesign® study is a post-market observational study to evaluate the rate of fistula closure in patients with persistent trans-sphincteric anal fistula who receive the Biodesign® Tissue graft as part of their LIFT procedure.
| Condition | Intervention |
|---|---|
|
Anal Fistula |
Device: reinforce soft tissue |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Ligation of the Intersphincteric Fistula Tract With Tissue Graft Placement for Treatment of Persistent Trans-sphincteric Anal Fistula |
Resource links provided by NLM:
Further study details as provided by Cook:
Primary Outcome Measures:
- Closure of the anal fistula [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Closure of the anal fistula [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | August 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| LIFT+Biodesign |
Device: reinforce soft tissue
reinforce soft tissue
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Regional and Community Hospitals
Criteria
Inclusion Criteria:
- Persistent primary or recurrent trans-sphincteric anal fistula
Exclusion Criteria:
- Patients with prior fistulotomy, fistulectomy, LIFT, cutting seton or advancement flap procedure
- Fistula with multiple tracts
- Recto-vaginal fistula
- Active infection in the anal fistula
- Physical allergies or cultural objections to porcine products
- Patient is not medically fit to undergo the LIFT procedure as judged by the treating physician
- Previous diagnosis of collagen disorder
- History of Crohn's Disease, Irritable Bowel Syndrome, radiation therapy in the rectoanal region
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01602081
Contacts
| Contact: Brenda Johnson | 765-463-7537 | bmjohnson@medinst.com |
Locations
| United States, California | |
| University of California Irvine | Recruiting |
| Orange, California, United States, 92868 | |
| Contact: Carlos Chavez 712-456-5396 chavezc@uci.edu | |
| United States, Illinois | |
| Rush University Medical Center | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Amanda Francescatti 312-942-7462 amanda_francescatti@rush.edu | |
| United States, Indiana | |
| Indiana University Hospitals | Recruiting |
| Indianapolis, Indiana, United States, 46202 | |
| Contact: Maryanne Bowyer-Cherry 317-274-0172 mbowyer@iupui.edu | |
| Kendrick Regional Center | Recruiting |
| Indianapolis, Indiana, United States, 46237 | |
| Contact: Katrina Yaggi 317-528-7821 Katrina.Yaggi@franciscanalliance.org | |
| United States, New York | |
| Mount Sinai Hospital | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Danielle Kruse 212-241-8033 danielle.kruse@mountsinai.org | |
| United States, Ohio | |
| Case Medical Center | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Contact: Tina Seafler 216-844-8447 Christina.Seafler@UHhospitals.org | |
| United States, Pennsylvania | |
| Hospital of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19106 | |
| Contact: Robyn Broach 215-776-8609 Robyn.Broach@uphs.upenn.edu | |
Sponsors and Collaborators
Cook
Investigators
| Principal Investigator: | Anthony Senagore, MD | University of Southern California |
More Information
No publications provided
| Responsible Party: | Cook |
| ClinicalTrials.gov Identifier: | NCT01602081 History of Changes |
| Other Study ID Numbers: | 10-012 |
| Study First Received: | May 16, 2012 |
| Last Updated: | April 3, 2013 |
| Health Authority: | None: No oversight authorities for this observational data collection gathering information on indication with an approved device. |
Keywords provided by Cook:
|
Anal fistula Ligation of the intersphincteric fistula tract LIFT Tissue graft |
Additional relevant MeSH terms:
|
Fistula Rectal Fistula Pathological Conditions, Anatomical Intestinal Fistula Digestive System Fistula |
Digestive System Diseases Intestinal Diseases Gastrointestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on June 17, 2013