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 - Full Text View

Sponsor:	ResQ Medical Ltd
Information provided by:	ResQ Medical Ltd
ClinicalTrials.gov Identifier:	NCT00653094

Purpose

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	Intervention
Crohn Disease Fistula	Device: Halevy kit

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease Fistulas

U.S. FDA Resources

Further study details as provided by ResQ Medical Ltd:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Control of sphincter will be evaluated by -the Cleveland continence score [ Time Frame: after follow up ] [ Designated as safety issue: Yes ]
Discharge from fistula will be evaluated by a questionnaire comparing the situation before and after surgery. [ Time Frame: after follow up ] [ Designated as safety issue: Yes ]
Healing of the fistula will be evaluated by a physical examination [ Time Frame: after follow up ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	10
Study Start Date:	June 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A	Device: Halevy kit the use of Halevy kit in Crohn patients with Fistulas

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00653094

Contacts

Contact: Eran Mr Goldin, Prof	02-6776848
Contact: Haim Mr Halevi, Dr.	052-2479211

Locations

Israel
Hadassah medical center	Not yet recruiting
Jerusalem, Israel
Contact: Eran Mr Goldin, Prof
Principal Investigator: Eran dr Goldin, Prof
Sub-Investigator: Yossi Mr Lissi, Dr.

Sponsors and Collaborators

ResQ Medical Ltd

Investigators

Principal Investigator:

Eran MR Goldin, Prof

Hadassah medical center

More Information

No publications provided

Responsible Party:	Elisha Yalin, ResQ Medical Ltd
ClinicalTrials.gov Identifier:	NCT00653094 History of Changes
Other Study ID Numbers:	H.K.prot.02-03-08
Study First Received:	April 1, 2008
Last Updated:	April 3, 2008
Health Authority:	Israel: Ministry of Health

Keywords provided by ResQ Medical Ltd:

crohn
fistula
surgery
fibrin glue
seton drainage

Additional relevant MeSH terms:

Crohn Disease
Fistula
Inflammatory Bowel Diseases
Gastroenteritis

Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on February 09, 2012