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Efficacy and Safety of an Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy

Tonsillar Hypertrophy Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. On basis of these finding and in view of the known safety profile (refer to Chen et.al ) and efficacy of current technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the IRE System in tonsillar reduction. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06187194
Study type Interventional
Source ENTire Medical Ltd.
Contact Danielle Vales
Phone +972 50-888-1100
Email danielle@carbo-fix.com
Status Recruiting
Phase N/A
Start date December 5, 2023
Completion date April 2026
View Details
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