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Zap instead of snip: electric pulses may treat Kids' blocked airways

NCT ID NCT06960239

Disease control Sponsor: ENTire Medical Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This study tested a new device that uses electrical pulses (IRE) to shrink enlarged tonsils in children, aiming to improve breathing without traditional surgery. Thirty-one children aged 3-18 with tonsil hypertrophy and airway obstruction took part. Researchers measured pain recovery and sleep quality changes over three months. The goal was to see if this approach is safe and works as well as standard tonsil surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Irreversible Electroporation (IRE) System (device)
What this could lead to
If successful, this device could offer a less painful alternative to traditional tonsil surgery for children with breathing problems.
What could go wrong
This was a small early feasibility study with only 31 participants, so results may not apply to all children. The device is new and long-term safety is not yet known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

31 people

The number who actually took part.

Started

Nov 2024

Finished

Oct 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age 3 - 18 years. * Tonsillar hypertrophy (more than 2 in Brodsky Grading System for Tonsils (BGST)). * Symptomatic Upper Airway obstruction. Exclusion Criteria: * 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. * Significant systemic illness (e.g., cancer, severe autoimmune disease, neurological disease). * Bleeding diathesis. * Known or suspected complications for any general or local anesthetic agents.

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Conditions

The condition(s) this trial relates to.

adenoid hypertrophy Airway Obstruction

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Tonsillar hypertrophy Upper airway obstruction

Contacts and locations

Locations

  • Republican Specialized Scientific-Practical Medical Center of Otorhinolaryngology and Head and Neck Diseases

    Tashkent, Uzbekistan

  • Spitalul Clinic de Urgență pentru copii "Maria S. Curie"

    Bucharest, Romania

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