Back to results

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

Primary Purpose

Crohn Disease, Fistula

Status

Unknown status

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Halevy kit

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring crohn, fistula, surgery, fibrin glue, seton drainage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Hadassah medical center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

Success of cannulation of the perianal fistula using the Pathway Probe Catheter will be evaluated

Success in using the cleaning brush in preparing the fistula for biologic adhesive injection will be evaluated

Success in inserting a draining Seton into the fistula tract by the Halevy kit

Success of injecting biologic adhesive into the fistula tract using the designated catheter will be evaluated

Secondary Outcome Measures

Control of sphincter will be evaluated by -the Cleveland continence score

Discharge from fistula will be evaluated by a questionnaire comparing the situation before and after surgery.

Healing of the fistula will be evaluated by a physical examination

Full Information

NCT ID

NCT00653094

First Posted

April 1, 2008

Last Updated

April 3, 2008

Sponsor

ResQ Medical Ltd

1. Study Identification

Unique Protocol Identification Number

NCT00653094

Brief 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

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

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Unknown status

Study Start Date

June 2008 (undefined)

Primary Completion Date

June 2009 (Anticipated)

Study Completion Date

August 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

ResQ Medical Ltd

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease, Fistula

Keywords

crohn, fistula, surgery, fibrin glue, seton drainage

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Intervention Type

Device

Intervention Name(s)

Halevy kit

Intervention Description

the use of Halevy kit in Crohn patients with Fistulas

Primary Outcome Measure Information:

Title

Success of cannulation of the perianal fistula using the Pathway Probe Catheter will be evaluated

Time Frame

after sugery

Title

Success in using the cleaning brush in preparing the fistula for biologic adhesive injection will be evaluated

Time Frame

after surgery

Title

Success in inserting a draining Seton into the fistula tract by the Halevy kit

Time Frame

after surgery

Title

Success of injecting biologic adhesive into the fistula tract using the designated catheter will be evaluated

Time Frame

after surgery

Secondary Outcome Measure Information:

Title

Control of sphincter will be evaluated by -the Cleveland continence score

Time Frame

after follow up

Title

Discharge from fistula will be evaluated by a questionnaire comparing the situation before and after surgery.

Time Frame

after follow up

Title

Healing of the fistula will be evaluated by a physical examination

Time Frame

after follow up

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eran Mr Goldin, Prof

Phone

02-6776848

First Name & Middle Initial & Last Name or Official Title & Degree

Haim Mr Halevi, Dr.

Phone

052-2479211

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eran MR Goldin, Prof

Organizational Affiliation

Hadassah Medical Organization

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hadassah medical center

City

Jerusalem

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Eran Mr Goldin, Prof

First Name & Middle Initial & Last Name & Degree

Eran dr Goldin, Prof

First Name & Middle Initial & Last Name & Degree

Yossi Mr Lissi, Dr.

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs