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

Crohn Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00653094
• Other study ID #: H.K.prot.02-03-08
• 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

• Crohn Disease
• Fistula

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