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

Launched by ENTIRE MEDICAL LTD. · Apr 28, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called Irreversible Electroporation (IRE) for children with enlarged tonsils, a condition known as adenotonsillar hypertrophy. Enlarged tonsils can cause breathing difficulties, especially during sleep, which can affect a child's overall health and quality of life. The study aims to determine if the IRE system is safe and effective for treating this condition in children aged 3 to 18 years who are experiencing symptoms of upper airway obstruction.

To participate in the trial, children must have noticeably enlarged tonsils and face challenges with breathing due to this condition. However, certain children are not eligible, including those who have had previous tonsil surgeries or have certain medical conditions that could complicate the treatment or anesthesia. If a child is eligible and joins the study, they will receive the IRE treatment and the researchers will monitor how well it works and if there are any safety concerns. This trial is currently active but not recruiting new participants, meaning they are already working with a group of children to gather important information about this novel treatment approach.

Gender

ALL

Eligibility criteria

• 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.