Tonsillar Hypertrophy, Upper Airway Obstruction
Conditions
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.
Interventions
DEVICEIRE System
Irreversible Electroporation (IRE) System for the Treatment of Upper Airway Obstruction due to Adenotonsillar Hypertrophy in Children
Sponsors
ENTire Medical Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Irreversible Electroporation (IRE) System for the Treatment of Upper Airway Obstruction due to Adenotonsillar Hypertrophy in Children
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days from treatment until no pain reported in Pain Scale. | 3 months post treatment | 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". |
| Evaluation of Sleep-Disordered Breathing | 3 months post treatment | 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. |
| 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). | 3 months post treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Time | Intraoperative | Procedure time reported is lower by 30% compared to literature for other adeno-tonsillar surgeries |
| Intraoperative blood loss | Intraoperative | Intraoperative blood loss (mL) |
Countries
Romania, Uzbekistan
Outcome results
None listed