Efficacy and Safety of an Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy

Tonsillar Hypertrophy Clinical Trial

Official title:

Evaluation of the Efficacy and Safety of an Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06187194
• Other study ID #: CLN 0137
• Status: Recruiting
• Phase: N/A
• Start date: December 5, 2023
• Est. completion date: April 2026

Study information

• Verified date: January 2024
• Source: ENTire Medical Ltd.
• Contact: Danielle Vales
• Phone: +972 50-888-1100
• Email: danielle[@]carbo-fix.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: April 2026
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertrophy
• Tonsillar Hypertrophy

Intervention

Device:
• IRE System
Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy

Locations

Country	Name	City	State
Romania	Saint Mary Hospital	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
ENTire Medical Ltd.

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of tonsil(s) size in accordance with the Brodsky Grading System for Tonsils (BGST) by at least one grade at 3 months compared to the Baseline.	Change of tonsillar hypertrophy by at least one grade and a change in post procedure related pain as compared to literature for other surgical treatment for reducing tonsil tissue mass.	3 months popst treatment