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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Irreversible Electroporation (IRE) System for the Treatment of Upper Airway Obstruction due to Adenotonsillar Hypertrophy in Children
Spitalul Clinic de Urgență pentru copii "Maria S. Curie"
Bucharest, Romania
RECRUITINGRepublican Specialized Scientific-Practical Medical Center of Otorhinolaryngology and Head and Neck Diseases
Tashkent, Uzbekistan
RECRUITINGNumber 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".
Time frame: 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.
Time frame: 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.
Time frame: 3 months post treatment
Sleep-Related Breathing Disorder Scale (PSQ-SRBD Scale)
Improvement in the PSQ-SRBD questionnaire score for Snoring, Sleeping and Behavior parameters, at 3 months compared to the Baseline. PSQ-SRBD scale contains 22 symptom items. Responses are "yes" = 1, "no" = 0, and "don't know"=missing. The mean response on non-missing items is the score, which can vary from 0 to 1. Higher scores suggest a higher risk for pediatric sleep-related breathing disorder.
Time frame: 3 months post treatment
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Procedure Time
Procedure time reported is lower by 30% compared to literature for other adeno-tonsillar surgeries
Time frame: Intraoperative
Intraoperative blood loss
Intraoperative blood loss (mL)
Time frame: Intraoperative