CompletedNot Applicable

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

Romania24 participantsStarted 2024-01-17

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Baseline and 3 months post-treatment

Pain VAS Score at 1-week Post-treatment

Timeframe: 1-week post-treatment

Trial details

NCT IDNCT06187194

SponsorENTire Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-11-15

Results submitted2026-03-15