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Safety and Efficacy of the Irreversible Electroporation (IRE) System for Adenotonsillar Hypertrophy in Children
Sponsor: ENTire Medical Ltd.
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.
Official title: Evaluation of the Efficacy and Safety of an Irreversible Electroporation (IRE) System for The Treatment of Upper Airway Obstruction Due to Adenotonsillar Hypertrophy in Children
Key Details
Gender
All
Age Range
3 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
31
Start Date
2024-11-14
Completion Date
2025-10-22
Last Updated
2026-07-07
Healthy Volunteers
Yes
Interventions
IRE System
Irreversible Electroporation (IRE) System for the Treatment of Upper Airway Obstruction due to Adenotonsillar Hypertrophy in Children
Locations (2)
Spitalul Clinic de Urgență pentru copii "Maria S. Curie"
Bucharest, Romania
Republican Specialized Scientific-Practical Medical Center of Otorhinolaryngology and Head and Neck Diseases
Tashkent, Uzbekistan