Image

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

Recruiting
18 - 70 years of age
Both
Phase N/A

Powered by AI

Overview

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.

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.

Study details

Tonsillar Hypertrophy

NCT06187194

ENTire Medical Ltd.

29 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.