NCT00653094

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2008

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

April 4, 2008

Status Verified

April 1, 2008

Enrollment Period

1 year

First QC Date

April 1, 2008

Last Update Submit

April 3, 2008

Conditions

Crohn DiseaseFistula

Keywords

crohnfistulasurgeryfibrin glueseton drainage

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • 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

Study Arms (1)

A

OTHER
Device: Halevy kit

Interventions

Halevy kitDEVICE

the use of Halevy kit in Crohn patients with Fistulas

A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah medical center

Jerusalem, Israel

Location

MeSH Terms

Conditions

Crohn DiseaseFistula

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Eran MR Goldin, Prof

    Hadassah Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eran Mr Goldin, Prof

CONTACT

02-6776848

Haim Mr Halevi, Dr.

CONTACT

052-2479211

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2008

First Posted

April 4, 2008

Study Start

June 1, 2008

Primary Completion

June 1, 2009

Study Completion

August 1, 2009

Last Updated

April 4, 2008

Record last verified: 2008-04

Locations

IL(1)