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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00653094
Other study ID # H.K.prot.02-03-08
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 1, 2008
Last updated April 3, 2008
Start date June 2008
Est. completion date August 2009

Study information

Verified date April 2008
Source ResQ Medical Ltd
Contact Eran Mr Goldin, Prof
Phone 02-6776848
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date August 2009
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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 Criteria:

- 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Halevy kit
the use of Halevy kit in Crohn patients with Fistulas

Locations

Country Name City State
Israel Hadassah medical center Jerusalem

Sponsors (1)

Lead Sponsor Collaborator
ResQ Medical Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success of cannulation of the perianal fistula using the Pathway Probe Catheter will be evaluated after sugery Yes
Primary Success in using the cleaning brush in preparing the fistula for biologic adhesive injection will be evaluated after surgery Yes
Primary Success in inserting a draining Seton into the fistula tract by the Halevy kit after surgery Yes
Primary Success of injecting biologic adhesive into the fistula tract using the designated catheter will be evaluated after surgery Yes
Secondary Control of sphincter will be evaluated by -the Cleveland continence score after follow up Yes
Secondary Discharge from fistula will be evaluated by a questionnaire comparing the situation before and after surgery. after follow up Yes
Secondary Healing of the fistula will be evaluated by a physical examination after follow up Yes
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