Clinical trial NCT00653094: 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
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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Crohn Disease
Fistula
Keywords: crohn
fistula
surgery
fibrin glue
seton drainage
Lead sponsor: ResQ Medical Ltd
Sponsor class: OTHER
First posted: 2008-04-04
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Success of cannulation of the perianal fistula using the Pathway Probe Catheter will be evaluated
timeFrame: after sugery
measure: Success in using the cleaning brush in preparing the fistula for biologic adhesive injection will be evaluated
timeFrame: after surgery
measure: Success in inserting a draining Seton into the fistula tract by the Halevy kit
timeFrame: after surgery
measure: Success of injecting biologic adhesive into the fistula tract using the designated catheter will be evaluated
timeFrame: after surgery
Secondary outcomes:
measure: Control of sphincter will be evaluated by -the Cleveland continence score
timeFrame: after follow up
measure: Discharge from fistula will be evaluated by a questionnaire comparing the situation before and after surgery.
timeFrame: after follow up
measure: Healing of the fistula will be evaluated by a physical examination
timeFrame: after follow up
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah medical center
Study officials:
affiliation: Hadassah Medical Organization
name: Eran MR Goldin, Prof
role: PRINCIPAL_INVESTIGATOR
References: