Safety and Efficacy of the Irreversible Electroporation (IRE) System for Adenotonsillar Hypertrophy in Children

ENTire Medical Ltd.

Status: Enrolling

Conditions: Upper Airway Obstruction; Tonsillar Hypertrophy

Treatments: Device: IRE System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06960239

CLN 0299

Details and patient eligibility

About

This is a multi-center, prospective, open-label, traditional feasibility study with a before-after study design. The study is designed to evaluate the safety and efficacy of an Irreversible Electroporation (IRE) System for the treatment of upper airway obstruction due to adenotonsillar hypertrophy in Children.

Full description

The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic tonsil(s) and adenoid while minimizing side effects and complications. Procedure time will also be reduced. The IRE System is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of the tonsils and adenoid volume. On basis of these finding and in view of the known safety profile and efficacy of current adeno-tonsillar reduction technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the IRE System in adeno-tonsillar reduction.

Enrollment: 40 estimated patients

Sex: All

Ages: 3 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 3 - 18 years.
• Tonsillar hypertrophy (more than 2 in Brodsky Grading System for Tonsils (BGST)).
• Symptomatic Upper Airway obstruction.

Exclusion criteria

• Age below 3 years, or above 18 years.
• Patients which underwent prior tonsillectomy or tonsillotomy.
• Body Mass Index (BMI) above the 95th percentile for patient's age and sex, as per the Centers for Disease Control and Prevention (CDC) growth charts.
• Patients with a pacemaker or similar electro stimulator implants.
• Patients for whom the anesthesia involves high risk.
• Epilepsy or other condition involving convulsions.
• Significant systemic illness (e.g., cancer, severe autoimmune disease, neurological disease).
• Bleeding diathesis.
• Known or suspected complications for any general or local anesthetic agents.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Enlarged tonsil(s) and/or adenoid mass will be reduced by ENTire IRE System.

Experimental group

Description:

The bi-polar IRE System locally applies short, high-voltage (HV) pulses, increasing the permeability of tissue cells, creating non-thermal irreversible electroporation (NTIRE). The energy is transferred via bipolar forceps handpiece causing irreversible cell membrane perforation and apoptosis resulting in tissue reduction. The clinical effect is anticipated within 2 to 4 weeks post-treatment.

Treatment:

Device: IRE System