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

Evaluation of the Efficacy and Safety of an Irreversible Electroporation (IRE) System for The Treatment of Upper Airway Obstruction Due to Adenotonsillar Hypertrophy in Children

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.

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.

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.