Evaluation of The Efficacy And Safety of An Irreversible Electroporation (IRE) System For Treatment of Inferior Turbinate Hypertrophy With Nasal Obstruction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 7
- 主要终点
- Reduction in Nasal Obstruction Symptom Evaluation Scale (NOSE)
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 hypertrophic inferior turbinate(s) causing nasal obstruction 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 inferior turbinate volume.
详细描述
The purpose of the IRE System is to address the clinical need for reducing the volume of hypertrophic inferior turbinate(s) causing nasal obstruction 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 interior turbinate 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.
- •Nasal Obstruction Symptom Evaluation (NOSE) score of ≥ 60 at the Baseline.
- •Hypertrophy of the inferior turbinate is the primary cause of the patient's nasal obstruction based on vasoconstriction test.
- •Did not improve with medical treatment, including topical nasal steroids for nasal obstruction for at least three months.
排除标准
- •Age below 18 years
- •Patients with a pacemaker or similar electro stimulator
- •Patients with caudal septal deviation that narrows the anterior nasal valve.
- •Patients with nasal polyps/tumors.
- •Patients with chronic rhinosinusitis.
- •Patients with Eosinophilia
- •Patients for whom the anesthesia involves high risk.
- •Patients with Epilepsy or other condition involving convulsions.
- •Patients with an inability to give informed consent and to complete self-reported questionnaires.
- •Patients with an inability to cooperate for treatment and follow-up.
- •Patients with severe heart disease.
- •Pregnancy or breastfeeding.
- •Previous inferior turbinate surgery.
研究组 & 干预措施
Enlarged Inferior Turbinate(s) 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 and causes irreversible cell membrane perforation and apoptosis. This results in tissue reduction within 2-4 weeks after treatment.
干预措施: IRE System (Device)
结局指标
主要结局
Reduction in Nasal Obstruction Symptom Evaluation Scale (NOSE)
时间窗: 3 months post treatment
A change of \> 20% in Nasal Obstruction Symptom Evaluation Scale scale and a \> 20% in the Nasal Obstruction VAS score as compared to screening visit.
次要结局
- Pain Visual Analog Scale (VAS)(up to 1 week post treatment and through study subject completion)
- A Sinonasal Outcome Test (SNOT-22) score(3 months post treatment)