N/A
Completed N=24
Efficacy and Safety of Irreversible Electroporation for Chronic Symptomatic Tonsillar Hypertrophy Treatment
Tonsillar Hypertrophy
Source: ClinicalTrials.gov NCT06187194 ↗
Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcomePrimary: Change of Tonsil(s) Size at 3 Months Compared to the Baseline. — -1.13; -1.26 Scores on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Tonsil(s) Size at 3 Months Compared to the Baseline. |
-1.13; -1.26 | — |
| PRIMARY Pain VAS Score at 1-week Post-treatment |
1.15 | — |
| SECONDARY Change in Snore VAS at 3-months Post-treatment Compared to Baseline |
-7.45 | — |
| SECONDARY Number of Participants With Complications Including Bleeding |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT06187194). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.