Tonsillar HypertrophyNCT06187194
Efficacy and Safety of Irreversible Electroporation for Chronic Symptomatic Tonsillar Hypertrophy Treatment
A study testing IRE System in people with Tonsillar Hypertrophy, run by ENTire Medical Ltd. at 1 site in Romania.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tonsillar Hypertrophy
- What is being tested?
- IRE System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteRomania
- Study dates
- 17 Jan 2024to 2 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 70 years.
- Tonsillar Hypertrophy of grade 2 or higher on the Brodsky Grading Scale for Tonsils (BGST).
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficacy and Safety of an Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy
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.
Read the detailed description
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.
- Conditions
- Tonsillar Hypertrophy
- Being tested
- IRE System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRE SystemDevice
Irreversible Electroporation (IRE) System for Tonsil Reduction for the Treatment of Chronic Symptomatic Tonsillar Hypertrophy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: IRE System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 1-week post-treatment
Secondary outcomes (2)
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.
Measured: 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.
Measured: During treatment, at discharge, at 1 week, 1 month, and 3 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2024
- Study start17 Jan 2024
- Primary completion15 Nov 2024
- Study completion2 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Tonsillar HypertrophyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- ENTire Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06187194
- Sponsor's protocol ID
- CLN 0137
- Status last verified
- Apr 2026
- First submitted
- 6 Sep 2023
- Last updated
- 29 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of an Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy
- ClinicalTrials.gov ID
- NCT06187194
- Acronym / sponsor ID
- CLN 0137
- Conditions
- Tonsillar Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- ENTire Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Jan 2024 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 2 Feb 2025 (actual)
- First posted
- 2 Jan 2024 (actual)
- Results
- Posted 29 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy
| Arm | Type | Receives |
|---|---|---|
| Enlarged tonsil(s) mass will be reduced by ENTire IRE System. | Experimental | Device: IRE SystemThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 - 70 years.
- Tonsillar Hypertrophy of grade 2 or higher on the Brodsky Grading Scale for Tonsils (BGST).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IRE SystemIrreversible Electroporation (IRE) System for Tonsil Reduction for the Treatment of Chronic Symptomatic Tonsillar Hypertrophy | Device | Enlarged tonsil(s) mass will be reduced by ENTire IRE System. |
Primary outcome
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).
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.
2 secondary outcomes
Change in Snore VAS at 3-months Post-treatment Compared to Baseline
Time frame: Baseline and 3 months post-treatment
Number of Participants With Complications Including Bleeding
Time frame: During treatment, at discharge, at 1 week, 1 month, and 3 months post-treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Tonsillar Hypertrophy
Recruiting
Photobiomodulation for Pediatric Hypertrophic Tonsils
Pediatric Sleep Apnea, Obstructive Sleep Apnea
Not yet recruiting
Full-wrap Versus Conventional Suspension for Reducing Soft Palate Injury Rate in Transoral Surgery
Adenoid Hypertrophy, Tonsillar Hypertrophy
Not yet recruiting
Randomized Clinical Trial for Tonsil Surgery in Adults With Obstructive Sleep Apnea and Enlarged Tonsils
Sleep Apnea, Obstructives, Tonsil Hypertrophy
Recruiting
Lateral Pharyngoplasty Outcomes in Children Undergoing Tonsillectomy
Sleep-Disordered Breathing, Sleep Apnea Syndromes in Children
Not yet recruitingObservational study
Evaluation of the Effects of Adenoidectomy and Adenotonsillectomy on Voice in Children
Adenoid Hypertrophy, Tonsillar Hypertrophy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRE System in people with Tonsillar Hypertrophy, run by ENTire Medical Ltd. at 1 site in Romania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Romania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Tonsil(s) Size at 3 Months Compared to the Baseline. (time frame: Baseline and 3 months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.