Status:
UNKNOWN
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
Lead Sponsor:
ResQ Medical Ltd
Conditions:
Crohn Disease
Fistula
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- Male and Female age greater than 18
- Patients suffering from Crohn's disease
- Patients with any number of simple or complex fistulas who require surgical intervention, requiring the insertion of a drain (Seton) into the fistula tract, and/or injection of biologic adhesive, or an anal fistula plug
- Able and willing to sign an informed consent
- Patient will be available for follow up.
Exclusion
- Pregnant or lactating woman. Woman of childbearing potential will undergo a pregnancy test at the beginning of the trial
- Known immunodeficiency.
- Exclusion Criteria for injecting biologic adhesive:
- Known allergy to fibrin glue or one of its components.
- An undrained perianal abscess, diagnosed by a physical examination or imaging methods.
- Known Alcohol or drug abuse
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00653094
Start Date
June 1 2008
End Date
August 1 2009
Last Update
April 4 2008
Active Locations (1)
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1
Hadassah medical center
Jerusalem, Israel