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

Last updated: March 16, 2026
Sponsor: ENTire Medical Ltd.
Overall Status: Completed

Phase

N/A

Condition

Nasal Obstruction

Acute Rhinitis

Treatment

IRE System

Clinical Study ID

NCT06438185
CLN 0157
  • Ages 18-70
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 nasalobstruction based on vasoconstriction test.

  • Did not improve with medical treatment, including topical nasal steroids for nasalobstruction for at least three months.

Exclusion

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-reportedquestionnaires.

  • 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

Total Participants: 48
Treatment Group(s): 1
Primary Treatment: IRE System
Phase:
Study Start date:
March 07, 2024
Estimated Completion Date:
June 27, 2025

Study 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.

Connect with a study center

  • Tel Aviv Sourasky Medical Center

    Tel Aviv,
    Israel

    Site Not Available

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, 08661
    Lithuania

    Site Not Available

  • Saint Mary Hospital

    Bucharest, 011172
    Romania

    Site Not Available

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

    Tashkent, Yashnabad District
    Uzbekistan

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.