An interventional study of Irreversible Electroporation in Airway Obstruction Upper, Tonsillectomy and Adenoidectomy Surgery, sponsored by ENTire Medical Ltd.. Not yet recruiting at 2 sites in United States. Open to participants aged 3 Years to 12 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by ENTire Medical Ltd. · Not applicable, Interventional, and Treatment
Among 47 studies in Hypertrophy with a site in United States — 8 open to participants now, 9 under way, none of them phase 3. Hypertrophy · United States.
Among the 47 studies in Hypertrophy with a site in United States, this one is the 8th largest by planned enrollment of the 41 interventional ones that give a count, is one of 3 that started in 2026, is one of 34 with no phase, and was the 47th registered.
140 studies on the registry are indexed under Hypertrophy; 23 are open to participants now.
Browse Hypertrophy studies →8 of the 47 studies in Hypertrophy with a site in United States are open now. Recruiting first, the newest first:
Atrium Therapeutics · Sites in United States
Ages 18–65
University of Wisconsin, Madison · Sites in United States
Ages 18–25 · Healthy volunteers
AVAVA, Inc. · Sites in United States
Ages 18–70 · Healthy volunteers
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute) · Sites in United States
Ages 20–89 · Women only
Montefiore Medical Center · Sites in United States
Ages 18+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 13 Hypertrophy studies recruiting now, 3 (23%) set no upper age limit and 7 (54%) stop at 75 or younger; none take children under 18; 9 take healthy volunteers.
This study: 3 Years to 12 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
47 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 2 · Phase 3 1 · Phase 4 2
First in 1995; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 73 is above the median of 34 across 113 interventional studies indexed under Hypertrophy.
Median enrollment 30 across the 41 interventional studies, 191 across the 6 observational. Of the 36 that completed or were terminated, 14 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
17 of 47 have an industry lead sponsor. The 10 most frequent:
ENTire Medical Ltd. is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
ENTire Medical Ltd. has 1 study filed under Hypertrophy — fewer than ten, so there is no comparison to draw.
3 of the studies in Hypertrophy with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05898074Indiana UniversityRole of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery | 2026-12-15 |
| NCT06115486Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)EXERT-BCH Exercise Regimen to Improve Muscle Mass After Treatment of Breast Cancer | 2027-01 |
| NCT07716319University of Wisconsin, MadisonComparison Between Eccentric Hamstring Training and Sprint-Specific Training | 2027-09 |
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Among the 47 studies in Hypertrophy with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Number of Participants With Device- or Procedure-Related Adverse Events (Bleeding, Readmission, Dehydration, or Emergency Department Visit)
Evaluation of the following device and/or procedure-related events: bleeding, readmission, dehydration and emergency department visits.
Time frame: 6 months
Time From Treatment to First Wong-Baker FACES Pain Scale Score of 2 or Below
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).
Time frame: From procedure until the end of the first week post procedure (7 days)
Change From Baseline in OSA-18 Total Score at 3 Months
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.
Time frame: 3 months post treatment
Change From Baseline in OSA-18 Total Score at 6 Months
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.
Time frame: 6 months post treatment
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2028, 18 months later.
Of 78 interventional studies with no phase under Hypertrophy, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 22. This study's planned 18 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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ENTire Medical Ltd.