Status:
RECRUITING
Safety and Efficacy of the Irreversible Electroporation (IRE) System for Adenotonsillar Hypertrophy in Children
Lead Sponsor:
ENTire Medical Ltd.
Conditions:
Tonsillar Hypertrophy
Upper Airway Obstruction
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief 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 Electropor...
Detailed Description
The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic tonsil(s) and adenoid while minimizing side effects and complications. Procedure time will also be...
Eligibility Criteria
Inclusion
- Age 3 - 18 years.
- Tonsillar hypertrophy (more than 2 in Brodsky Grading System for Tonsils (BGST)).
- Symptomatic Upper Airway obstruction.
Exclusion
- Age below 3 years, or above 18 years.
- Patients which underwent prior tonsillectomy or tonsillotomy.
- Body Mass Index (BMI) above the 95th percentile for patient's age and sex, as per the Centers for Disease Control and Prevention (CDC) growth charts.
- Patients with a pacemaker or similar electro stimulator implants.
- Patients for whom the anesthesia involves high risk.
- Epilepsy or other condition involving convulsions.
- Significant systemic illness (e.g., cancer, severe autoimmune disease, neurological disease).
- Bleeding diathesis.
- Known or suspected complications for any general or local anesthetic agents.
Key Trial Info
Start Date :
November 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06960239
Start Date
November 14 2024
End Date
May 1 2026
Last Update
August 6 2025
Active Locations (2)
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1
Spitalul Clinic de Urgență pentru copii "Maria S. Curie"
Bucharest, Romania
2
Republican Specialized Scientific-Practical Medical Center of Otorhinolaryngology and Head and Neck Diseases
Tashkent, Uzbekistan