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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

NCT ID: NCT00653094

Last Updated: 2008-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2009-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn Disease Fistula

Keywords

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crohn fistula surgery fibrin glue seton drainage

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type OTHER

Halevy kit

Intervention Type DEVICE

the use of Halevy kit in Crohn patients with Fistulas

Interventions

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Halevy kit

the use of Halevy kit in Crohn patients with Fistulas

Intervention Type DEVICE

Eligibility Criteria

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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.

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ResQ Medical Ltd

OTHER

Sponsor Role lead

Responsible Party

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ResQ Medical Ltd

Principal Investigators

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Eran MR Goldin, Prof

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah medical center

Jerusalem, , Israel

Site Status

Countries

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Israel

Central Contacts

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Eran Mr Goldin, Prof

Role: CONTACT

Phone: 02-6776848

Haim Mr Halevi, Dr.

Role: CONTACT

Phone: 052-2479211

Facility Contacts

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Eran Mr Goldin, Prof

Role: primary

Other Identifiers

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H.K.prot.02-03-08

Identifier Type: -

Identifier Source: org_study_id