An interventional study of IRE System in Tonsillar Hypertrophy, sponsored by ENTire Medical Ltd.. Completed at 1 site in Romania. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by ENTire Medical Ltd. · Not applicable, Interventional, and 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.
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.
ENTire Medical Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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).
Time frame: 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.
Time frame: 1-week post-treatment
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.
Time frame: 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.
Time frame: During treatment, at discharge, at 1 week, 1 month, and 3 months post-treatment.
A total of 24 adults were enrolled into a single-arm trial. A total of 25 subjects were screened for the study; one subject did not meet the inclusion criteria following anesthesiology review.
| Milestone | ENTire IRE System Arm |
|---|---|
| Started | 24 |
| Completed | 23 |
| Not completed | 1 |
| Withdrew: Withdrawal by subject | 1 |
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).
| Scores on a scale | ENTire IRE System Arm |
|---|---|
| Left Tonsil | -1.13 ± 0.34 |
| Right Tonsil | -1.26 ± 0.45 |
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.
| score on a scale | ENTire IRE System Arm |
|---|---|
| Pain VAS Score at 1-week Post-treatment | 1.15 ± 0.88 |
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.
| scores on a scale | ENTire IRE System Arm |
|---|---|
| Change in Snore VAS at 3-months Post-treatment Compared to Baseline | -7.45 ± 7.09 |
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.
| Participants | ENTire IRE System Arm |
|---|---|
| Number of Participants With Complications Including Bleeding | 0 |
Collected over Day 0 (after commencement of treatment with the ENTire IRE System) to 3 Months (+21 days) follow-up.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ENTire IRE System Arm | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
During the study, 24 patients were screened and consented and enrolled in the study. One patient withdrew from the study after the one-month post-procedure follow-up. This patient was still included in the intent-to-treat data analysis with the data obtained.
| Age, Categorical(Participants) | ENTire IRE System Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 22 |
| >=65 years | 2 |
| Age, Continuous(years) | ENTire IRE System Arm |
|---|---|
| Mean | 36.5 ± 12.7 |
| Sex: Female, Male(Participants) | ENTire IRE System Arm |
|---|---|
| Female | 13 |
| Male | 11 |
| Race/Ethnicity, Customized(Participants) | ENTire IRE System Arm |
|---|---|
| Caucasian | 24 |
| Region of Enrollment(Participants) | ENTire IRE System Arm |
|---|---|
| Romania | 24 |
| Tonsil Size (Brodsky Grading Scale for Tonsil (BGST))(Participants) | ENTire IRE System Arm |
|---|---|
| Left Tonsil — Grade 0 | 0 |
| Left Tonsil — Grade 1 | 0 |
| Left Tonsil — Grade 2 | 15 |
| Left Tonsil — Grade 3 | 5 |
| Left Tonsil — Grade 4 | 4 |
| Right Tonsil — Grade 0 | 0 |
| Right Tonsil — Grade 1 | 0 |
| Right Tonsil — Grade 2 | 16 |
| Right Tonsil — Grade 3 | 4 |
| Right Tonsil — Grade 4 | 4 |
| Snore Visual Analog Scale (VAS)(Scores on a scale) | ENTire IRE System Arm |
|---|---|
| Mean | 10.43 ± 8.27 |
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ENTire Medical Ltd.