Pediatric Adeno-Tonsillar Hypertrophy Treatment Post-Approval Study

November 5, 2026 updated by: ENTire Medical Ltd.

This study is a prospective, multi-center, single-arm study of pediatric subjects (age 3-12) with Sleep-Disordered Breathing ("SDB") due to adeno-tonsillar hypertrophy which are treated with the ENTire IRE System.

Subjects will be followed for six (6) months post-treatment. The objective of the study is to provide an ongoing safety and effectiveness assessment of the ENTire IRE System in treating pediatric adeno-tonsillar hypertrophy.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80045
        • Children's Hospital Colorado
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

3 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients are 3-12 years of age.
  • Tonsillar hypertrophy of grade 2 or more on the Brodsky Grading System for Tonsils ("BGST").
  • Children with SDB scheduled for adeno-tonsillar surgery after an otolaryngology evaluation.

Exclusion Criteria:

  1. Patients with a pacemaker, cochlear or similar electro stimulator implants.
  2. Patients for whom the anesthesia involves high risk.
  3. Significant illness (e.g., cancer, severe autoimmune disease, neurological disease, severe heart disease).
  4. Craniofacial anomalies.
  5. Patients which underwent prior tonsillectomy or tonsillotomy.
  6. Epilepsy or other conditions involving convulsions.
  7. Parent/Guardian inability to give informed consent and to complete reported questionnaires.
  8. Any other reason the investigator deems the subject is unfit for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Enlarged tonsil(s) and/or adenoid mass will be reduced by ENTire IRE System.
Device: Irreversible Electroporation

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Device- or Procedure-Related Adverse Events (Bleeding, Readmission, Dehydration, or Emergency Department Visit)
Time Frame: 6 months

Evaluation of the following device and/or procedure-related events: bleeding, readmission, dehydration and emergency department visits.
6 months
Time From Treatment to First Wong-Baker FACES Pain Scale Score of 2 or Below
Time Frame: From procedure until the end of the first week post procedure (7 days)

For each participant, the number of days from treatment until the first daily pain score of 2 or below on the Wong-Baker FACES® Pain Scale. Pain is assessed after treatment and then daily for the first 7 days post-procedure. The scale ranges from 0 ("No hurt") to 10 ("Hurts worst"). Minimum value is 0 and maximum value is 10; higher scores indicate more pain (a worse outcome).
From procedure until the end of the first week post procedure (7 days)
Change From Baseline in OSA-18 Total Score at 3 Months
Time Frame: 3 months post treatment

The Obstructive Sleep Apnea-18 (OSA-18) questionnaire is completed by the parent or caregiver at baseline and at 3 months post treatment. The outcome is the change in OSA-18 total score from baseline to 3 months. The questionnaire has 18 questions, each rated from 1 ("None of the time") to 7 ("All of the time"). The total score ranges from 18 (minimum) to 126 (maximum); higher scores indicate more severe symptoms and greater impairment (a worse outcome). No formal hypothesis will be tested.
3 months post treatment
Change From Baseline in OSA-18 Total Score at 6 Months
Time Frame: 6 months post treatment

The Obstructive Sleep Apnea-18 (OSA-18) questionnaire is completed by the parent or caregiver at baseline and at 6 months post treatment. The outcome is the change in OSA-18 total score from baseline to 6 months. The questionnaire has 18 questions, each rated from 1 ("None of the time") to 7 ("All of the time"). The total score ranges from 18 (minimum) to 126 (maximum); higher scores indicate more severe symptoms and greater impairment (a worse outcome). No formal hypothesis will be tested.
6 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ENTire Medical Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 5, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 6, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 6, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 29, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLN 0330

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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