Status:
ACTIVE_NOT_RECRUITING
Efficacy and Safety of Irreversible Electroporation for Chronic Symptomatic Tonsillar Hypertrophy Treatment
Lead Sponsor:
ENTire Medical Ltd.
Conditions:
Tonsillar Hypertrophy
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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...
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...
Eligibility Criteria
Inclusion
- Age 18 - 70 years.
- Tonsillar Hypertrophy of grade 2 or higher on the BGST.
Exclusion
- 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.
Key Trial Info
Start Date :
December 5 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06187194
Start Date
December 5 2023
End Date
April 1 2026
Last Update
March 26 2025
Active Locations (1)
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1
Saint Mary Hospital
Bucharest, Romania