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

Evaluation of the Efficacy and Safety of an Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy

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.

Study Overview

• Status: Completed
• Conditions: Tonsillar Hypertrophy
• Intervention / Treatment: Device: IRE System

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 Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania
    • Saint Mary Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 - 70 years.
• Tonsillar Hypertrophy of grade 2 or higher on the Brodsky Grading Scale for Tonsils (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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Enlarged tonsil(s) 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 and causes irreversible cell membrane perforation and apoptosis. This results in tissue reduction within 2-4 weeks after treatment.

Device: IRE System; Irreversible Electroporation (IRE) System for Tonsil Reduction for the Treatment of Chronic Symptomatic Tonsillar Hypertrophy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Tonsil(s) Size at 3 Months Compared to the Baseline.	Change of tonsil(s) size in accordance with the Brodsky Grading System for Tonsils (BGST) as assessed 3 months post-treatment compared to the Baseline assessment. BGST consists of a scale from 0 to 4, evaluating tonsil(s) airway obstruction based on the following grading system: Grade 0 denotes a complete absence of obstruction on the oropharyngeal airway (i.e. best). Grade 1 is defined as tonsil(s) that sit just outside of the tonsillar fossa with obstruction of less than 25% of the airway. Grade 2 Tonsil(s) are readily seen in the airway- 25 to 50% of the airway is obstructed. Grade 3 Tonsil(s) denote a 50 to 75% obstruction of the airway. Grade 4 represents Tonsil(s) involving a greater than 75% obstruction of the airway (worst). A negative outcome value indicates a reduction in Brodsky grade (tonsil size).	Baseline and 3 months post-treatment
Pain VAS Score at 1-week Post-treatment	Pain VAS score at 1-week follow-up; The Pain Visual Analog Scale ("Pain VAS") at 1-week follow-up visit assessed using a horizontal 10cm visual analog scale ranging from 0 "No Pain" to 10 "Worst Pain Imaginable". Scores are obtained by measuring the distance in cm from the left origin of the line (0) to the point indicated with a vertical mark placed by the participant to indicate their current level of pain.	1-week post-treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Snore VAS at 3-months Post-treatment Compared to Baseline	Patient overall well-being was assessed using verified subject-reported Snore VAS at three months post-treatment compared to the baseline. The participants were asked to estimate the severity of their snoring using a 10 cm visual analogue scale (VAS) from 0 (no snoring/"Never") to 10 (very severe snoring/"All the time"). The total score is the sum of the scores of the three questions, for a total out of 30, with the minimum possible total score of 0 (no snoring/"Never") to 30 (very severe snoring/"All the time"). The mean change in subjective snoring severity Snore (VAS) at 3 months after treatment with IRE was the primary outcome measurement. A negative score indicates a reduction in snoring quality of life symptoms. A larger negative score is a better outcome.	Baseline and 3 months post-treatment
Number of Participants With Complications Including Bleeding	The study safety and risk success was evaluated by device-related, intraoperative and postoperative serious adverse events and also through documented physical assessments of the incidence of post-treatment reactions. The presence and documentation of complications were assessed during treatment, at discharge, at 1 week, 1 month, and 3 months post-treatment.	During treatment, at discharge, at 1 week, 1 month, and 3 months post-treatment.

Collaborators and Investigators

• Sponsor: ENTire Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2024
• Primary Completion (Actual): November 15, 2024
• Study Completion (Actual): February 2, 2025

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: December 16, 2023
• First Posted (Actual): January 2, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hypertrophy
• Other Study ID Numbers: CLN 0137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No