The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic inferior turbinate(s) causing nasal obstruction 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 the inferior turbinate volume.
The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic inferior turbinate(s) causing nasal obstruction 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 interior turbinate reduction.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction.
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
RECRUITINGVilnius University Hospital Santaros Klinikos
Vilnius, Lithuania
RECRUITINGSaint Mary Hospital
Bucharest, Romania
ACTIVE_NOT_RECRUITINGRepublican Specialized Scientific and Practical Medical Center for Otorhinolaryngology and Head and Neck Diseases
Tashkent, Yashnabad District, Uzbekistan
RECRUITINGReduction in Nasal Obstruction Symptom Evaluation Scale (NOSE)
A change of \> 20% in Nasal Obstruction Symptom Evaluation Scale scale and a \> 20% in the Nasal Obstruction VAS score as compared to screening visit.
Time frame: 3 months post treatment
A Sinonasal Outcome Test (SNOT-22) score
A Sinonasal Outcome Test (SNOT-22) score improvement by at least a 8.9 point reduction at 3 months post treatment.
Time frame: 3 months post treatment
Pain Visual Analog Scale (VAS)
Low to moderate Pain VAS (VAS/Pain VAS) score (1-3 on a VAS Scale) post treatment.
Time frame: up to 1 week post treatment and through study subject completion
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