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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by ResQ Medical Ltd.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
ResQ Medical Ltd
ClinicalTrials.gov Identifier:
NCT00653094
First received: April 1, 2008
Last updated: April 3, 2008
Last verified: April 2008
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014