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Electric pulses zap away enlarged tonsils without surgery

NCT ID NCT06187194

Symptom relief 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a new device that uses high-voltage electric pulses to shrink enlarged tonsils without cutting. Twenty-four adults with grade 2 or higher tonsil hypertrophy received the treatment. The goal was to reduce tonsil size and pain, with results measured at 3 months.

What this could mean

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

Active substance
IRE System (device using high voltage electric pulses to shrink tonsils)
What this could lead to
If successful, this could offer a less painful, quicker alternative to traditional tonsil surgery for adults with enlarged tonsils.
What could go wrong
This was a small, early study with only 24 participants, so results may not apply to everyone. The device is new and long-term effects are unknown.

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

24 people

The number who actually took part.

Started

Jan 2024

Finished

Feb 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

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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 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.

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Conditions

The condition(s) this trial relates to.

adenoid hypertrophy

As listed by the trial registrant

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

Tonsillar hypertrophy

Contacts and locations

Locations

  • Saint Mary Hospital

    Bucharest, Romania

More trials for these conditions

Other studies related to the condition(s) this trial covers.