Clinical Trial

Safety and Efficacy of the Irreversible Electroporation (IRE) System for Adenotonsillar Hypertrophy in Children

Completed
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Summary
This is a multi-center, prospective, open-label, traditional feasibility study with a before-after study design. The study is designed to evaluate the safety and efficacy of an Irreversible Electroporation (IRE) System for the treatment of upper airway obstruction due to adenotonsillar hypertrophy in Children.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-04-28; most recent amendment 2026-07-06.
Status change: Recruiting → Completed 2026-03-16
Status change: Active, Not Recruiting → Recruiting 2025-08-05
Trial Details
NCT Number NCT06960239
Lead Sponsor ENTire Medical Ltd.
Conditions Tonsillar Hypertrophy, Upper Airway Obstruction
Enrollment 31 participants
Start Date 2024-11-14
Primary Completion 2025-10-22 (estimated)
Study Completion 2025-10-22 (estimated)
Updated on ClinicalTrials.gov 2026-07-08