Efficacy and Safety of Irreversible Electroporation for Chronic Symptomatic Tonsillar Hypertrophy Treatment

ENTire Medical Ltd.

Status: Active, not recruiting

Conditions: Tonsillar Hypertrophy

Treatments: Device: IRE System

Study type: Interventional

Funder types: Industry

Identifiers

NCT06187194

CLN 0137

Details and patient eligibility

About

The purpose of the IRE System is to address the clinical need for reducing the volume of chronic symptomatic hypertrophic tonsil(s) 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.

Full description

The purpose of the IRE System is to address the clinical need for reducing the volume of chronic symptomatic hypertrophic tonsil(s) 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 tonsillar reduction.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 - 70 years.
• Tonsillar Hypertrophy of grade 2 or higher on the BGST.

Exclusion criteria

• Age below 18 years.
• Patients with a pacemaker or similar electro stimulator.
• Patients for whom the anesthesia involves high risk.
• Epilepsy or other condition involving convulsions.
• Inability to give informed consent and to complete self-reported questionnaires.
• Patients with an inability to cooperate for treatment and follow-up.
• Severe heart disease.
• Pregnancy or breastfeeding.
• Significant systemic illness (e.g., cancer, severe autoimmune disease, neurological disease).
• Bleeding diathesis.
• Patients suffering from obesity as indicated by a body mass index (BMI) > 32kg/m2.
• Known or suspected complications for any general or local anesthetic agents and/or any antibiotic medications.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Enlarged tonsil(s) mass 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