Efficacy and Safety of Irreversible Electroporation for Chronic Symptomatic Tonsillar Hypertrophy Treatment

Not Applicable

Active, not recruiting

• Conditions: Tonsillar Hypertrophy
• Interventions: Device: IRE System

• Registration Number: NCT06187194
• Lead Sponsor: ENTire Medical Ltd.

Brief Summary

The purpose of the IRE System is to address the clinical need for reducing the volume of chronic symptomatic hypertrophic tonsil(s) 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 tonsil volume.

Detailed Description

The purpose of the IRE System is to address the clinical need for reducing the volume of chronic symptomatic hypertrophic tonsil(s) 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 tonsil volume. On basis of these finding and in view of the known safety profile (refer to Chen et.al ) and efficacy of current technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the IRE System in tonsillar reduction.

Study Timeline

• Study First Submitted: 2023-09-06
• Study Start: 2023-12-05
• Study First Submitted QC: 2023-12-16
• Study First Posted: 2024-01-02
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-23
• Last Update Posted: 2025-03-26
• Primary Completion: 2025-09
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Age 18 - 70 years.
• Tonsillar Hypertrophy of grade 2 or higher on the BGST.

Exclusion Criteria

• Age below 18 years.
• Patients with a pacemaker or similar electro stimulator.
• Patients for whom the anesthesia involves high risk.
• Epilepsy or other condition involving convulsions.
• Inability to give informed consent and to complete self-reported questionnaires.
• Patients with an inability to cooperate for treatment and follow-up.
• Severe heart disease.
• Pregnancy or breastfeeding.
• Significant systemic illness (e.g., cancer, severe autoimmune disease, neurological disease).
• Bleeding diathesis.
• Patients suffering from obesity as indicated by a body mass index (BMI) > 32kg/m2.
• Known or suspected complications for any general or local anesthetic agents and/or any antibiotic medications.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enlarged tonsil(s) mass will be reduced by ENTire IRE System.	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 and causes irreversible cell membrane perforation and apoptosis. This results in tissue reduction within 2-4 weeks after treatment.

Primary Outcome Measures

Name	Time	Method
Change of tonsil(s) size in accordance with the Brodsky Grading System for Tonsils (BGST) by at least one grade at 3 months compared to the Baseline.	3 months popst treatment	Change of tonsillar hypertrophy by at least one grade and a change in post procedure related pain as compared to literature for other surgical treatment for reducing tonsil tissue mass.

Trial Locations

Locations (1)

Saint Mary Hospital; 🇷🇴 Bucharest, Romania