An interventional study of IRE System in Inferior Turbinate Hypertrophy, Nasal Obstruction and Turbinate; Hypertrophy Mucous Membrane, sponsored by ENTire Medical Ltd.. Completed at 4 sites in 4 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-03-17.
Sponsored by ENTire Medical Ltd. · Not applicable, Interventional, and Treatment
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.
108 studies on the registry are indexed under Nasal Obstruction; 27 are open to participants now.
This study's enrollment of 48 is close to the median of 52 across 80 interventional studies indexed under Nasal Obstruction.
Browse Nasal Obstruction studies →ENTire Medical Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
The bi-polar IRE System locally applies short, high-voltage (HV) pulses, increasing the permeability of tissue cells, creating non-thermal irreversible electroporation (NTIRE). The energy is transferred via bipolar forceps and causes irreversible cell membrane perforation and apoptosis. This results in tissue reduction within 2-4 weeks after treatment.
Device: IRE System
Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction.
Also known as: ENtire IRE System
Reduction 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
Plan to share: No
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This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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ENTire Medical Ltd.