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Efficacy and Safety of Irreversible Electroporation for Chronic Symptomatic Tonsillar Hypertrophy Treatment
Sponsor: ENTire Medical Ltd.
Summary
The purpose of the IRE System is to address the clinical need for reducing the volume of chronic symptomatic hypertrophic tonsil(s) while minimizing side effects and complications. Procedure time will also be reduced. The IRE System is designed to be more comfortable for patients, as it employs a noninvasive procedure using a high voltage pulsed electric field to create irreversible nanopores in the cell membrane, leading to cell death and the reduction of tonsil volume.
Official title: Evaluation of the Efficacy and Safety of an Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2024-01-17
Completion Date
2025-02-02
Last Updated
2026-04-29
Healthy Volunteers
No
Conditions
Interventions
IRE System
Irreversible Electroporation (IRE) System for Tonsil Reduction for the Treatment of Chronic Symptomatic Tonsillar Hypertrophy
Locations (1)
Saint Mary Hospital
Bucharest, Romania