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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-14

Study Completion Date

2026-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Tonsillar Hypertrophy Upper Airway Obstruction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

IRE System

Intervention Type DEVICE

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

Interventions

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IRE System

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

Intervention Type DEVICE

Other Intervention Names

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ENtire IRE System

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes