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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 4
- 主要终点
- Number of days from treatment until no pain reported in Pain Scale.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 3 - 18 years.
- •Tonsillar hypertrophy (more than 2 in Brodsky Grading System for Tonsils (BGST)).
- •Symptomatic Upper Airway obstruction.
排除标准
- •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.
研究组 & 干预措施
Enlarged tonsil(s) and/or adenoid mass will be reduced by ENTire IRE System.
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.
干预措施: IRE System (Device)
结局指标
主要结局
Number of days from treatment until no pain reported in Pain Scale.
时间窗: 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
时间窗: 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).
时间窗: 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.
次要结局
- Sleep-Related Breathing Disorder Scale (PSQ-SRBD Scale)(3 months post treatment)
- Procedure Time(Intraoperative)
- Intraoperative blood loss(Intraoperative)