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

NCT06438185 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-03-17

No results posted yet for this 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.

Conditions

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

Interventions

DEVICE

IRE System

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

Sponsors & Collaborators

  • ENTire Medical Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-07
Primary Completion
2025-06-27
Completion
2025-06-27

Countries

  • Israel
  • Lithuania
  • Romania
  • Uzbekistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06438185 on ClinicalTrials.gov