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Not yet recruiting Not applicable Interventional

Pediatric Adeno-Tonsillar Hypertrophy Treatment Post-Approval Study

ClinicalTrials.gov ID: NCT07931534

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This page only displays public information reproduced from the official ClinicalTrials.gov record NCT07931534. It adds no medical advice, opinions, or eligibility judgments. The official record remains the source of truth for eligibility criteria, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 12, 2026, 7:17 PM EST

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID
NCT07931534
Recruitment status
Not yet recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
ENTire Medical Ltd.
Industry
Enrollment
73 participants

Conditions and interventions

Eligibility (public fields only)

Age range
3 Years to 12 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Nov 5, 2026 (Estimated)
Primary completion
May 6, 2028 (Estimated)
Completion
May 6, 2028 (Estimated)
Last update posted
Nov 12, 2026

2026 – 2028

United States locations

U.S. sites
2
U.S. states
2
U.S. cities
2
Facility City State ZIP Site status
Children's Hospital Colorado Denver Colorado 80045 —
UT Southwestern Medical Center Dallas Texas 75390 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT07931534, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 12, 2026 · Synced Nov 12, 2026

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