Evaluation of the Efficacy and Safety of an Irreversible Electroporation (IRE) System for Tonsil Reduction for The Treatment of Chronic Symptomatic Tonsillar Hypertrophy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change of tonsil(s) size in accordance with the Brodsky Grading System for Tonsils (BGST) by at least one grade at 3 months compared to the Baseline.
研究概览
简要总结
The purpose of the IRE System is to address the clinical need for reducing the volume of chronic symptomatic hypertrophic tonsil(s) 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 tonsil volume.
详细描述
The purpose of the IRE System is to address the clinical need for reducing the volume of chronic symptomatic hypertrophic tonsil(s) 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 tonsil volume. On basis of these finding and in view of the known safety profile (refer to Chen et.al ) and efficacy of current technologies, the purpose of the current study is to prospectively determine the efficacy and safety of the IRE System in 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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 70 years.
- •Tonsillar Hypertrophy of grade 2 or higher on the BGST.
排除标准
- •Age below 18 years.
- •Patients with a pacemaker or similar electro stimulator.
- •Patients for whom the anesthesia involves high risk.
- •Epilepsy or other condition involving convulsions.
- •Inability to give informed consent and to complete self-reported questionnaires.
- •Patients with an inability to cooperate for treatment and follow-up.
- •Severe heart disease.
- •Pregnancy or breastfeeding.
- •Significant systemic illness (e.g., cancer, severe autoimmune disease, neurological disease).
- •Bleeding diathesis.
- •Patients suffering from obesity as indicated by a body mass index (BMI) > 32kg/m
- •Known or suspected complications for any general or local anesthetic agents and/or any antibiotic medications.
结局指标
主要结局
Change of tonsil(s) size in accordance with the Brodsky Grading System for Tonsils (BGST) by at least one grade at 3 months compared to the Baseline.
时间窗: 3 months popst treatment
Change of tonsillar hypertrophy by at least one grade and a change in post procedure related pain as compared to literature for other surgical treatment for reducing tonsil tissue mass.
次要结局
未报告次要终点