CompletedNot Applicable

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

Romania, Uzbekistan31 participantsStarted 2024-11-14

Plain-language summary

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.

Who can participate

Age range3 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Number of days from treatment until no pain reported in Pain Scale.

Timeframe: 3 months post treatment

Evaluation of Sleep-Disordered Breathing

Timeframe: 3 months post treatment

Number of participants with treatment-related adverse events as assessed by a standardized 0-3 severity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).

Timeframe: 3 months post treatment

Trial details

NCT IDNCT06960239

SponsorENTire Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-10-22

View on ClinicalTrials.gov More Tonsillar Hypertrophy trials

Plain-language summary

Who can participate

Age range3 Years – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Number of days from treatment until no pain reported in Pain Scale.

Timeframe: 3 months post treatment

Evaluation of Sleep-Disordered Breathing

Timeframe: 3 months post treatment

Number of participants with treatment-related adverse events as assessed by a standardized 0-3 severity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).

Timeframe: 3 months post treatment