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NCT Number: NCT06960239

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.

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Key information

Conditions

Tonsillar Hypertrophy Airway Obstruction Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Upper Airway Obstruction

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spitalul Clinic de Urgență pentru copii "Maria S. Curie", Bucharest, Romania

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IRE System

Device

Irreversible Electroporation (IRE) System for the Treatment of Upper Airway Obstruction due to Adenotonsillar Hypertrophy in Children

Other names: ENtire IRE System

Primary outcomes

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

    Time frame: 3 months post treatment

    The number of days from treatment until no pain is reported using the Wong-Baker FACES® Pain Scale is non-inferior to literature for other adenotonsillar surgeries. The Wong-Baker FACES® Pain Scale (Pain Scale) is a horizontal scale ranging from 0 "No hurt" to 10 "Hurts worst".

  2. Evaluation of Sleep-Disordered Breathing

    Time frame: 3 months post treatment

    Obstructive Sleep Apnea (OSA) -18 questionnaire scoring change by 30% at 3 months compared to the Baseline. OSA -18 questionnaire includes 18 questions that rates the severity of different aspects of a child's life affected by OSA. Ratings are provided on a scale of 1 to 7, where a score of 1 refers to "None of the time" and a score of 7 "All of time". A final summed score could vary from 18 to 126, with higher scores indicating more severe symptoms and greater impairment.

  3. 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).

    Time frame: 3 months post treatment

    Physician assessment of the incidence of post-treatment Adverse Events using a 0 to 3 grading scale (0=none, 1=mild, 2=moderate, 3=severe) following treatment and recording any additional side effects and comparing to literature for other adeno-tonsillar surgeries to check for non-inferiority.

Secondary outcomes

  1. Procedure Time

    Time frame: Intraoperative

    Procedure time reported is lower by 30% compared to literature for other adeno-tonsillar surgeries

  2. Intraoperative blood loss

    Time frame: Intraoperative

    Intraoperative blood loss (mL)

Sponsors and collaborators

Lead sponsor

ENTire Medical Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 7, 2025
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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