Fibrin Glue for Perianal Fistulas in Crohn's Disease: a Randomized Controlled Trial
NCT00723047 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 77
Last updated 2011-09-05
Summary
This multicenter, randomized, controlled trial was conducted by the Groupe d'Etude Thérapeutique des Affections Inflammatoires du tube Digestif (GETAID) to evaluate the efficacy and safety of the injection of fibrin glue in perianal fistulas tracts of patients with CD. The institutional Independent Ethics Committee of Marseille, France and of Liège, Belgium approved the protocol for each participating centers. Recruitment took place at 12 sites (11 in France and 1 in Belgium)
Conditions
Interventions
- PROCEDURE
-
Fibrin glue injection in fistula
Sponsors & Collaborators
-
Nycomed
collaborator INDUSTRY -
Société Nationale Française de Gastroentérologie
collaborator OTHER -
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-11-30
- Primary Completion
- 2006-06-30
- Completion
- 2006-08-31
Countries
- Belgium
- France
Study Locations
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