Tonsillar HypertrophyNCT06960239
Safety and Efficacy of the Irreversible Electroporation (IRE) System for Adenotonsillar Hypertrophy in Children
A study testing IRE System in people with Tonsillar Hypertrophy and Upper Airway Obstruction, run by ENTire Medical Ltd. at 2 sites in 2 countries.
Trial summary
This is a multi-center, prospective, open-label, traditional feasibility study with a before-after study design. The study is designed to evaluate the safety and efficacy of an Irreversible Electroporation (IRE) System for the treatment of upper airway obstruction due to adenotonsillar hypertrophy in Children. Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tonsillar Hypertrophy, Upper Airway Obstruction
- 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
- 31 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 14 Nov 2024to 22 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 3 - 18 years.
- Tonsillar hypertrophy (more than 2 in Brodsky Grading System for Tonsils (BGST)).
- Symptomatic Upper Airway obstruction.
Who cannot join
- Age below 3 years, or above 18 years.
- Patients which underwent prior tonsillectomy or tonsillotomy.
- Body Mass Index (BMI) above the 95th percentile for patient's age and sex, as per the Centers for Disease Control and Prevention (CDC) growth charts.
- Patients with a pacemaker or similar electro stimulator implants.
- Patients for whom the anesthesia involves high risk.
- Epilepsy or other condition involving convulsions.
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- Significant systemic illness (e.g., cancer, severe autoimmune disease, neurological disease).
- Bleeding diathesis.
- Known or suspected complications for any general or local anesthetic agents.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Romania1 site
Spitalul Clinic de Urgență pentru copii "Maria S. Curie"
Bucharest
Uzbekistan1 site
Republican Specialized Scientific-Practical Medical Center of Otorhinolaryngology and Head and Neck Diseases
Tashkent
About this study
Official title: Evaluation of the Efficacy and Safety of an Irreversible Electroporation (IRE) System for The Treatment of Upper Airway Obstruction Due to Adenotonsillar Hypertrophy in Children
This is a multi-center, prospective, open-label, traditional feasibility study with a before-after study design. The study is designed to evaluate the safety and efficacy of an Irreversible Electroporation (IRE) System for the treatment of upper airway obstruction due to adenotonsillar hypertrophy in Children.
Read the detailed description
The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic tonsil(s) and adenoid 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 the tonsils and adenoid volume. On basis of these finding and in view of the known safety profile and efficacy of current adeno-tonsillar reduction technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the IRE System in adeno-tonsillar reduction.
- Conditions
- Tonsillar Hypertrophy, Upper Airway Obstruction
- Being tested
- IRE System
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRE SystemDevice
Also called ENtire IRE System
Irreversible Electroporation (IRE) System for the Treatment of Upper Airway Obstruction due to Adenotonsillar Hypertrophy in Children
| Study group | Role | What they receive |
|---|---|---|
| Enlarged tonsil(s) and/or adenoid 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 handpiece causing irreversible cell membrane perforation and apoptosis resulting in tissue reduction. The clinical effect is anticipated within 2 to 4 weeks post-treatment. Receives: Device: IRE System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days from treatment until no pain reported in Pain Scale.
The number of days from treatment until no pain is reported using the Wong-Baker FACES® Pain Scale is non-inferior to literature for other adenotonsillar surgeries. The Wong-Baker FACES® Pain Scale (Pain Scale) is a horizontal scale ranging from 0 "No hurt" to 10 "Hurts worst".
Measured: 3 months post treatment
Evaluation of Sleep-Disordered Breathing
Obstructive Sleep Apnea (OSA) -18 questionnaire scoring change by 30% at 3 months compared to the Baseline. OSA -18 questionnaire includes 18 questions that rates the severity of different aspects of a child's life affected by OSA. Ratings are provided on a scale of 1 to 7, where a score of 1 refers to "None of the time" and a score of 7 "All of time". A final summed score could vary from 18 to 126, with higher scores indicating more severe symptoms and greater impairment.
Measured: 3 months post treatment
Number of participants with treatment-related adverse events as assessed by a standardized 0-3 severity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Physician assessment of the incidence of post-treatment Adverse Events using a 0 to 3 grading scale (0=none, 1=mild, 2=moderate, 3=severe) following treatment and recording any additional side effects and comparing to literature for other adeno-tonsillar surgeries to check for non-inferiority.
Measured: 3 months post treatment
Secondary outcomes (2)
Procedure Time
Procedure time reported is lower by 30% compared to literature for other adeno-tonsillar surgeries
Measured: Intraoperative
Intraoperative blood loss
Intraoperative blood loss (mL)
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start14 Nov 2024
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 the Treatment of Upper Airway Obstruction due to Adenotonsillar Hypertrophy in Children
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT06960239
- Sponsor's protocol ID
- CLN 0299
- Status last verified
- Jul 2026
- First submitted
- 10 Apr 2025
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Khasanov U, Matmuratov ZS, Coman A, Buruiana AM, Passali D, Passali FM, DeRowe A. Irreversible Electroporation for the Treatment of Pediatric Adenotonsillar Hypertrophy. J Clin Med. 2026 Jul 2;15(13):5189. doi: 10.3390/jcm15135189.
PubMed 42452649
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 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 The Treatment of Upper Airway Obstruction Due to Adenotonsillar Hypertrophy in Children
- ClinicalTrials.gov ID
- NCT06960239
- Acronym / sponsor ID
- CLN 0299
- Conditions
- Tonsillar Hypertrophy, Upper Airway Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- ENTire Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Nov 2024 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-center, prospective, open-label, traditional feasibility study with a before-after study design. The study is designed to evaluate the safety and efficacy of an Irreversible Electroporation (IRE) System for the treatment of upper airway obstruction due to adenotonsillar hypertrophy in Children.
Detailed description
The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic tonsil(s) and adenoid 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 the tonsils and adenoid volume. On basis of these finding and in view of the known safety profile and efficacy of current adeno-tonsillar reduction technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the IRE System in adeno-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 the Treatment of Upper Airway Obstruction due to Adenotonsillar Hypertrophy in Children
| Arm | Type | Receives |
|---|---|---|
| Enlarged tonsil(s) and/or adenoid 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 handpiece causing irreversible cell membrane perforation and apoptosis resulting in tissue reduction. The clinical effect is anticipated within 2 to 4 weeks post-treatment. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Age 3 - 18 years.
- Tonsillar hypertrophy (more than 2 in Brodsky Grading System for Tonsils (BGST)).
- Symptomatic Upper Airway obstruction.
Key exclusion criteria (9 listed)
- Age below 3 years, or above 18 years.
- Patients which underwent prior tonsillectomy or tonsillotomy.
- Body Mass Index (BMI) above the 95th percentile for patient's age and sex, as per the Centers for Disease Control and Prevention (CDC) growth charts.
- Patients with a pacemaker or similar electro stimulator implants.
- Patients for whom the anesthesia involves high risk.
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 SystemAlso: ENtire IRE SystemIrreversible Electroporation (IRE) System for the Treatment of Upper Airway Obstruction due to Adenotonsillar Hypertrophy in Children | Device | Enlarged tonsil(s) and/or adenoid mass will be reduced by ENTire IRE System. |
Primary outcome
Number of days from treatment until no pain reported in Pain Scale.
Time frame: 3 months post treatment
The number of days from treatment until no pain is reported using the Wong-Baker FACES® Pain Scale is non-inferior to literature for other adenotonsillar surgeries. The Wong-Baker FACES® Pain Scale (Pain Scale) is a horizontal scale ranging from 0 "No hurt" to 10 "Hurts worst".
Evaluation of Sleep-Disordered Breathing
Time frame: 3 months post treatment
Obstructive Sleep Apnea (OSA) -18 questionnaire scoring change by 30% at 3 months compared to the Baseline. OSA -18 questionnaire includes 18 questions that rates the severity of different aspects of a child's life affected by OSA. Ratings are provided on a scale of 1 to 7, where a score of 1 refers to "None of the time" and a score of 7 "All of time". A final summed score could vary from 18 to 126, with higher scores indicating more severe symptoms and greater impairment.
Number of participants with treatment-related adverse events as assessed by a standardized 0-3 severity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
Time frame: 3 months post treatment
Physician assessment of the incidence of post-treatment Adverse Events using a 0 to 3 grading scale (0=none, 1=mild, 2=moderate, 3=severe) following treatment and recording any additional side effects and comparing to literature for other adeno-tonsillar surgeries to check for non-inferiority.
2 secondary outcomes
Procedure Time
Time frame: Intraoperative
Intraoperative blood loss
Time frame: Intraoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Results publication: PubMed 42452649Khasanov U, Matmuratov ZS, Coman A, Buruiana AM, Passali D, Passali FM, DeRowe A. Irreversible Electroporation for the Treatment of Pediatric Adenotonsillar Hypertrophy. J Clin Med. 2026 Jul 2;15(13):5189. doi: 10.3390/jcm15135189.
- Individual participant dataSharing planned: No
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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.
2 sites in 2 countries: 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 and Upper Airway Obstruction, run by ENTire Medical Ltd. at 2 sites in 2 countries.
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 3 inclusion and 9 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Romania, Uzbekistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of days from treatment until no pain reported in Pain Scale. (time frame: 3 months post treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06960239, which also lists 1 linked publication.
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 8 Jul 2026.