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

Sponsor

ResQ Medical Ltd (Other)

Overall Status

Unknown status

CT.gov ID

NCT00653094

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Crohn Disease Fistula	Device: Halevy kit	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Study Start Date :

Jun 1, 2008

Anticipated Primary Completion Date :

Jun 1, 2009

Anticipated Study Completion Date :

Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: A	Device: Halevy kit the use of Halevy kit in Crohn patients with Fistulas

Arm

Intervention/Treatment

Other: A

Device: Halevy kit

the use of Halevy kit in Crohn patients with Fistulas

Outcome Measures

Primary Outcome Measures

Success of cannulation of the perianal fistula using the Pathway Probe Catheter will be evaluated [after sugery]
Success in using the cleaning brush in preparing the fistula for biologic adhesive injection will be evaluated [after surgery]
Success in inserting a draining Seton into the fistula tract by the Halevy kit [after surgery]
Success of injecting biologic adhesive into the fistula tract using the designated catheter will be evaluated [after surgery]

Secondary Outcome Measures

Control of sphincter will be evaluated by -the Cleveland continence score [after follow up]
Discharge from fistula will be evaluated by a questionnaire comparing the situation before and after surgery. [after follow up]
Healing of the fistula will be evaluated by a physical examination [after follow up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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