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

NCT06438185 | Completed

• 1 other identifier: CLN 0157
• Study Type: interventional
• Target: 48
• Locations: 4 countries
• Sites: 4

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.

Conditions

Inferior Turbinate Hypertrophy; Nasal Obstruction; Turbinate; Hypertrophy Mucous Membrane

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• A Sinonasal Outcome Test (SNOT-22) score

  3 months post treatment

• Pain Visual Analog Scale (VAS)

  up to 1 week post treatment and through study subject completion

Study Arms (1)

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

EXPERIMENTAL

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

Interventions

IRE System DEVICE

Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction.

Also known as: ENtire IRE System

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ENTire Medical Ltd.: lead

Study Sites (4)

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

Location

Saint Mary Hospital

Bucharest, 011172, Romania

Location

Republican Specialized Scientific and Practical Medical Center for Otorhinolaryngology and Head and Neck Diseases

Tashkent, Yashnabad District, Uzbekistan

Location

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Irreversible Electroporation (IRE) System for Inferior Turbinate Hypertrophy with Nasal Obstruction

Study Record Dates

• First Submitted: May 23, 2024
• First Posted: May 31, 2024
• Study Start: March 7, 2024
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

RO (1); UZ (1); LI (1); IL (1)