Safety and Efficacy of the Irreversible Electroporation (IRE) System for 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.

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.