Efficacy And Safety of An IRE System For Treatment of Inferior Turbinate Hypertrophy

Evaluation of The Efficacy And Safety of An Irreversible Electroporation (IRE) System For Treatment of Inferior Turbinate Hypertrophy With Nasal Obstruction

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.

Study Overview

• Status: Completed
• Conditions: Nasal Obstruction; Inferior Turbinate Hypertrophy; Turbinate; Hypertrophy Mucous Membrane
• Intervention / Treatment: Device: IRE System

Detailed Description

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
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Tel Aviv, Israel
    • Tel Aviv Sourasky Medical Center
• Lithuania
  • Vilnius, Lithuania, 08661
    • Vilnius University Hospital Santaros Klinikos
• Romania
  • Bucharest, Romania, 011172
    • Saint Mary Hospital
• Uzbekistan
  • Yashnabad District
    • Tashkent, Yashnabad District, Uzbekistan
      • Republican Specialized Scientific and Practical Medical Center for Otorhinolaryngology and Head and Neck Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 - 70 years.
• Nasal Obstruction Symptom Evaluation (NOSE) score of ≥ 60 at the Baseline.
• Hypertrophy of the inferior turbinate is the primary cause of the patient's nasal obstruction based on vasoconstriction test.
• Did not improve with medical treatment, including topical nasal steroids for nasal obstruction for at least three months.

Exclusion Criteria:

• Age below 18 years
• Patients with a pacemaker or similar electro stimulator
• Patients with caudal septal deviation that narrows the anterior nasal valve.
• Patients with nasal polyps/tumors.
• Patients with chronic rhinosinusitis.
• Patients with Eosinophilia
• Patients for whom the anesthesia involves high risk.
• Patients with Epilepsy or other condition involving convulsions.
• Patients with an inability to give informed consent and to complete self-reported questionnaires.
• Patients with an inability to cooperate for treatment and follow-up.
• Patients with severe heart disease.
• Pregnancy or breastfeeding.
• Previous inferior turbinate surgery.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Enlarged Inferior Turbinate(s) will be reduced by ENTire IRE System.; 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.; Other Names: ENtire IRE System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	up to 1 week post treatment and through study subject completion

Collaborators and Investigators

• Sponsor: ENTire Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2024
• Primary Completion (Actual): June 27, 2025
• Study Completion (Actual): June 27, 2025

Study Registration Dates

• First Submitted: May 23, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Nose Diseases; Otorhinolaryngologic Diseases; Respiratory Insufficiency; Airway Obstruction; Nasal Obstruction
• Other Study ID Numbers: CLN 0157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No