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

ResQ Medical

Status: Unknown

Conditions: Fistula; Crohn Disease

Treatments: Device: Halevy kit

Study type: Interventional

Funder types: Other

Identifiers

NCT00653094

H.K.prot.02-03-08

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

A

Other group

Treatment:

Device: Halevy kit