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Completed

NCT Number: NCT06187194

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

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.

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Key information

Conditions

Tonsillar Hypertrophy

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Saint Mary Hospital

Bucharest, Romania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IRE System

Device

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

Primary outcomes

  1. Change of Tonsil(s) Size at 3 Months Compared to the Baseline.

    Time frame: Baseline and 3 months post-treatment

    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).

  2. Pain VAS Score at 1-week Post-treatment

    Time frame: 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.

Secondary outcomes

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

    Time frame: Baseline and 3 months post-treatment

    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.

  2. Number of Participants With Complications Including Bleeding

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

    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.

Sponsors and collaborators

Lead sponsor

ENTire Medical Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jan 2, 2024
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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