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| A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas |
| Link to the ClinicalTrials.gov record | Information obtained from ClinicalTrials.gov on February 23, 2012 |
| Title of trial/grant title | A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas |
| Current status of trial | Recruiting |
| Sponsors and collaborators | Cook Cook Biotech Incorporated Cook Ireland, Ltd. |
| Information provided by | Cook |
| ClinicalTrials.gov identifier | NCT00545441 |
| Purpose | The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure. |
| Condition(s) | Anal Fistula |
| Intervention(s) | Device: Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP) Device: Flap |
| Phase | N/A |
| Study type and design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
| Official title | A Randomized Clinical Trial Comparing Surgisis AFP to Advancement Flap for the Repair of Anal Fistulas |
| Primary outcome | Healing One Year |
| Secondary outcome | Quality of Life, Continence, Complications One Year |
| Study start | June 2008 |
| Minimum age | 18 Years |
| Maximum age | N/A |
| Gender | Both |
| Eligibility criteria | Inclusion Criteria: - Over eighteen years old - Clinical diagnosis of primary anal fistula categorized as transsphincteric, suprasphincteric, or extrasphincteric in nature - Pre-placement of seton required for at least 6 weeks prior to surgical treatment - Willing to sign informed consent and share data with study sponsor and Surgisis AFP manufacturer Exclusion Criteria: - Recurrent fistula tracts - J-pouch fistulas - Superficial fistulas - Fistulas with active abscess, infection, or acute inflammation - History of Chron's Disease - History of Ulcerative Colitis - History of HIV or other immune system disease - History of collagen disease - History of radiation to the anorectal region - Allergies to pig tissue or pig products - Religious or cultural objection to the use of pig tissue |
| Overall contact | Jason P. Hodde, MS tel: 765-497-3355 hodde@cookbiotech.com |
| Study chairs or principal investigators | Thilo Schwandner, MD, Principal Investigator, Justus-Liebig-Universitat Giessen |
| Locations | Germany Krankenhaus Waldfriede Berlin Status: Recruiting Contact: Dr. Roland Scherer tel: +4930/81810151 r.scherer@waldriede.de Germany Justus-Liebig-Universitat Giessen Giessen 35385 Status: Recruiting Contact: Thilo Schwandner, MD tel: +49-641-994-4200 t.schwandner@web.de Germany End-und Dickdarmzentrum Hannover Hannover Status: Recruiting Contact: Michael Roblick tel: +49 511 646 646-0 info@edh.de Germany Enddarmzentrum Mannheim Mannheim Status: Recruiting Contact: Prof. Dr. med. Alexander Herold tel: +49 621 1234 7570 alex@heroldhomeline.de Germany Caritas-Krankenhaus St. Joseph Regensburg Status: Recruiting Contact: Dr. Alois Fuerst tel: +49941/7823310 afuerst@caritasstjosef.de Germany St. Joseph Hospital Wiesbaden Status: Recruiting Contact: Dr. Ulrike Soetje tel: +49611/1771376 drulrikesoetje@web.de |
| Study ID numbers | 07-006 |
| Last updated | December 19, 2011 |
| Record first received | October 16, 2007 |
| ClinicalTrials.gov identifier | NCT00545441 |
| Download date | Information obtained from ClinicalTrials.gov on February 23, 2012 |
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