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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-07

Study Completion Date

2026-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Inferior Turbinate Hypertrophy Nasal Obstruction Turbinate; Hypertrophy Mucous Membrane

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

IRE System

Intervention Type DEVICE

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

Interventions

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IRE System

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

Intervention Type DEVICE

Other Intervention Names

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ENtire IRE System

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No