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Sponsored by: |
ResQ Medical Ltd |
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Information provided by: | ResQ Medical Ltd |
ClinicalTrials.gov Identifier: | NCT00653094 |
Today, there is no available equipment specifically designed for the procedure of instillation of fibrin glue for the repair of perianal fistulae. The currently used equipment involves surgical tools generally used for fistula surgeries, and injection syringes designed for general use. The injection of biological adhesives is performed using standard adhesive syringes that are not specially designed for use in perianal fistulae. The use of the semi-flexible metal probes can cause trauma to tissue and injure the fistula tract, creating an additional path, and the injection syringe and catheter are often inconvenient for perianal use. This study was design to test the use of Halevy kit, by gastroenterology specialist, as a non traumatic probing, mechanical debridement and injecting or inserting device for treatment substances in perianal fistulas. In this study a gastroenterologist will perform the procedure, in each procedure a trained colorectal surgeon will be present during the surgery to oversee the procedure and to provide surgical help if required.
Condition | Intervention |
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Crohn Disease Fistula |
Device: Halevy kit |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | An Open Label, Prospective, One Arm, Feasibility, Study for The Use of Halevy Kit for the Treatment of Perianal Fistulas in Patients With Crohn's Disease |
Estimated Enrollment: | 10 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A |
Device: Halevy kit
the use of Halevy kit in Crohn patients with Fistulas
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for injecting biologic adhesive:
Contact: Eran Mr Goldin, Prof | 02-6776848 | |
Contact: Haim Mr Halevi, Dr. | 052-2479211 |
Israel | |
Hadassah medical center | |
jerusalem, Israel |
Principal Investigator: | Eran MR Goldin, Prof | Hadassah medical center |
Responsible Party: | ResQ Medical Ltd ( Elisha Yalin ) |
Study ID Numbers: | H.K.prot.02-03-08 |
Study First Received: | April 1, 2008 |
Last Updated: | April 3, 2008 |
ClinicalTrials.gov Identifier: | NCT00653094 |
Health Authority: | Israel: Ministry of Health |
crohn fistula surgery fibrin glue seton drainage |
Pathological Conditions, Anatomical Digestive System Diseases Fibrin Tissue Adhesive Gastrointestinal Diseases Crohn Disease |
Inflammatory Bowel Diseases Gastroenteritis Intestinal Diseases Fistula |