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

ENTire Medical Ltd.

Status: Enrolling

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

Treatments: Device: IRE System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06438185

CLN 0157

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Device: IRE System