Clinical trial NCT06960239: Safety and Efficacy of the Irreversible Electroporation (IRE) System for Adenotonsillar Hypertrophy in Children
Official title: Evaluation of the Efficacy and Safety of an Irreversible Electroporation (IRE) System for The Treatment of Upper Airway Obstruction Due to Adenotonsillar Hypertrophy in Children
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tonsillar Hypertrophy
Upper Airway Obstruction
Lead sponsor: ENTire Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-07
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Irreversible Electroporation (IRE) System for the Treatment of Upper Airway Obstruction due to Adenotonsillar Hypertrophy in Children
Primary purpose: TREATMENT

Brief summary: This is a multi-center, prospective, open-label, traditional feasibility study with a before-after study design. The study is designed to evaluate the safety and efficacy of an Irreversible Electroporation (IRE) System for the treatment of upper airway obstruction due to adenotonsillar hypertrophy in Children.

Detailed description: The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic tonsil(s) and adenoid 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 the tonsils and adenoid volume. On basis of these finding and in view of the known safety profile and efficacy of current adeno-tonsillar reduction technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the IRE System in adeno-tonsillar reduction.

Eligibility criteria: Inclusion Criteria:

* Age 3 - 18 years.
* Tonsillar hypertrophy (more than 2 in Brodsky Grading System for Tonsils (BGST)).
* Symptomatic Upper Airway obstruction.

Exclusion Criteria:

* Age below 3 years, or above 18 years.
* Patients which underwent prior tonsillectomy or tonsillotomy.
* Body Mass Index (BMI) above the 95th percentile for patient's age and sex, as per the Centers for Disease Control and Prevention (CDC) growth charts.
* Patients with a pacemaker or similar electro stimulator implants.
* Patients for whom the anesthesia involves high risk.
* Epilepsy or other condition involving convulsions.
* Significant systemic illness (e.g., cancer, severe autoimmune disease, neurological disease).
* Bleeding diathesis.
* Known or suspected complications for any general or local anesthetic agents.

Primary outcomes:
measure: Number of days from treatment until no pain reported in Pain Scale.
timeFrame: 3 months post treatment
measure: Evaluation of Sleep-Disordered Breathing
timeFrame: 3 months post treatment
measure: Number of participants with treatment-related adverse events as assessed by a standardized 0-3 severity scale (0 = none, 1 = mild, 2 = moderate, 3 = severe).
timeFrame: 3 months post treatment
Secondary outcomes:
measure: Sleep-Related Breathing Disorder Scale (PSQ-SRBD Scale)
timeFrame: 3 months post treatment
measure: Procedure Time
timeFrame: Intraoperative
measure: Intraoperative blood loss
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Tashkent
country: Uzbekistan
facility: Republican Specialized Scientific-Practical Medical Center of Otorhinolaryngology and Head and Neck Diseases
Study officials:
References: