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

Not Applicable

Recruiting

• Conditions: Nasal Obstruction; Turbinate; Hypertrophy Mucous Membrane; Inferior Turbinate Hypertrophy
• Interventions: Device: IRE System

• Registration Number: NCT06438185
• Lead Sponsor: ENTire Medical Ltd.

Brief Summary

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.

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 Timeline

• Study Start: 2024-03-07
• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-29
• Study First Posted: 2024-05-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-23
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-09
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Enlarged Inferior Turbinate(s) will be reduced by ENTire IRE System.	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.

Primary Outcome Measures

Name	Time	Method
Reduction in Nasal Obstruction Symptom Evaluation Scale (NOSE)	3 months post treatment	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.

Secondary Outcome Measures

Name	Time	Method
Pain Visual Analog Scale (VAS)	up to 1 week post treatment and through study subject completion	Low to moderate Pain VAS (VAS/Pain VAS) score (1-3 on a VAS Scale) post treatment.
A Sinonasal Outcome Test (SNOT-22) score	3 months post treatment	A Sinonasal Outcome Test (SNOT-22) score improvement by at least a 8.9 point reduction at 3 months post treatment.

Trial Locations

Locations (3)

Tel Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Vilnius University Hospital Santaros Klinikos; 🇱🇹 Vilnius, Lithuania

Saint Mary Hospital; 🇷🇴 Bucharest, Romania