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

January 22, 2024 updated by: ENTire Medical Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enlarged tonsil(s) mass 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.
Device: IRE System
Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy
Other Names:
  • ENtire IRE System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 3 months popst treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ENTire Medical Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

December 16, 2023

First Posted (Actual)

January 2, 2024

Study Record Updates

Last Update Posted (Actual)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 22, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLN 0137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Tonsillar Hypertrophy

Clinical Trials on IRE System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe