Clinical trial NCT06187194: Efficacy and Safety of Irreversible Electroporation for Chronic Symptomatic Tonsillar Hypertrophy Treatment
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tonsillar Hypertrophy
Lead sponsor: ENTire Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2024-01-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 3 months popst treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: Saint Mary Hospital
Study officials:
References: