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

NCT06960239 | Completed

• 1 other identifier: CLN 0299
• Study Type: interventional
• Target: 31
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Upper Airway Obstruction; Tonsillar Hypertrophy

Outcome Measures

Primary Outcomes (3)

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

  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".

  3 months post treatment

• Evaluation of Sleep-Disordered Breathing

  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 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).

  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.

  3 months post treatment

Secondary Outcomes (3)

• Sleep-Related Breathing Disorder Scale (PSQ-SRBD Scale)

  3 months post treatment

• Procedure Time

  Intraoperative

• Intraoperative blood loss

  Intraoperative

Study Arms (1)

Enlarged tonsil(s) and/or adenoid mass will be reduced by ENTire IRE System.

EXPERIMENTAL

The bi-polar IRE System locally applies short, high-voltage (HV) pulses, increasing the permeability of tissue cells, creating non-thermal irreversible electroporation (NTIRE). The energy is transferred via bipolar forceps handpiece causing irreversible cell membrane perforation and apoptosis resulting in tissue reduction. The clinical effect is anticipated within 2 to 4 weeks post-treatment.

Device: IRE System

Interventions

IRE System DEVICE

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

Also known as: ENtire IRE System

Enlarged tonsil(s) and/or adenoid mass will be reduced by ENTire IRE System.

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 3 - 18 years.
• Tonsillar hypertrophy (more than 2 in Brodsky Grading System for Tonsils (BGST)).
• Symptomatic Upper Airway obstruction.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ENTire Medical Ltd.: lead

Study Sites (2)

Spitalul Clinic de Urgență pentru copii "Maria S. Curie"

Bucharest, Romania

Location

Republican Specialized Scientific-Practical Medical Center of Otorhinolaryngology and Head and Neck Diseases

Tashkent, Uzbekistan

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: May 7, 2025
• Study Start: November 14, 2024
• Primary Completion: October 22, 2025
• Study Completion: October 22, 2025
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

UZ (1); RO (1)