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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Enlarged tonsil(s) and/or adenoid mass will be reduced by ENTire IRE System. | Experimental | 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 handpiece causing irreversible cell membrane perforation and apoptosis resulting in tissue reduction. The clinical effect is anticipated within 2 to 4 weeks post-treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRE System | Device | Irreversible Electroporation (IRE) System for the Treatment of Upper Airway Obstruction due to Adenotonsillar Hypertrophy in Children |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of days from treatment until no pain reported in Pain Scale. | The number of days from treatment until no pain is reported using the Wong-Baker FACES® Pain Scale is non-inferior to literature for other adenotonsillar surgeries. The Wong-Baker FACES® Pain Scale (Pain Scale) is a horizontal scale ranging from 0 "No hurt" to 10 "Hurts worst". | 3 months post treatment |
| Evaluation of Sleep-Disordered Breathing | Obstructive Sleep Apnea (OSA) -18 questionnaire scoring change by 30% at 3 months compared to the Baseline. OSA -18 questionnaire includes 18 questions that rates the severity of different aspects of a child's life affected by OSA. Ratings are provided on a scale of 1 to 7, where a score of 1 refers to "None of the time" and a score of 7 "All of time". A final summed score could vary from 18 to 126, with higher scores indicating more severe symptoms and greater impairment. | 3 months post treatment |
| 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). | Physician assessment of the incidence of post-treatment Adverse Events using a 0 to 3 grading scale (0=none, 1=mild, 2=moderate, 3=severe) following treatment and recording any additional side effects and comparing to literature for other adeno-tonsillar surgeries to check for non-inferiority. | 3 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Time | Procedure time reported is lower by 30% compared to literature for other adeno-tonsillar surgeries | Intraoperative |
| Intraoperative blood loss | Intraoperative blood loss (mL) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spitalul Clinic de Urgență pentru copii "Maria S. Curie" | Bucharest | Romania | ||||
| Republican Specialized Scientific-Practical Medical Center of Otorhinolaryngology and Head and Neck Diseases |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | Khasanov U, Matmuratov Z, Coman A, Buruiană AM, Passali D, Passali FM, DeRowe A. Irreversible Electroporation for the Treatment of Pediatric Adenotonsillar Hypertrophy. Journal of Clinical Medicine. 2026; 15(13):5189. https://doi.org/10.3390/jcm15135189 |
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| ID | Term |
|---|---|
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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Irreversible Electroporation (IRE) System for the Treatment of Upper Airway Obstruction due to Adenotonsillar Hypertrophy in Children
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| Intraoperative |
| Tashkent |
| Uzbekistan |