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

NCT06187194 | Completed Results

• 1 other identifier: CLN 0137
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Tonsillar Hypertrophy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Snore VAS at 3-months Post-treatment Compared to Baseline

  Baseline and 3 months post-treatment

• Number of Participants With Complications Including Bleeding

  During treatment, at discharge, at 1 week, 1 month, and 3 months post-treatment.

Study Arms (1)

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

Device: IRE System

Interventions

IRE System DEVICE

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

Enlarged tonsil(s) mass will be reduced by ENTire IRE System.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ENTire Medical Ltd.: lead

Study Sites (1)

Saint Mary Hospital

Bucharest, Romania

Location

Results Point of Contact

• Title: Danielle Vales
• Organization: ENTire Medical

info@ent-ire.com

972-9-9511511

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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 Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: January 2, 2024
• Study Start: January 17, 2024
• Primary Completion: November 15, 2024
• Study Completion: February 2, 2025
• Last Updated: April 29, 2026
• Results First Posted: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1)