Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode (ECE50)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 384
- 试验地点
- 1
- 主要终点
- Confirm the safety
研究概览
简要总结
The objective of this registry is to confirm the safety and the performance of the ECE50 in medical routine by collecting data.
详细描述
The Endoscopic Cap Electrode (ECE50) has been designed for the delivery of electrostimulation to selected laryngeal muscles. The primary objective of this registry is to retrieve real-life data on the safety and performance of the Endoscopic Cap in medical routine. Subject's participation will last a maximum of 2 hours. Upon successful conclusion of the screening session starts the testing session of the ECE50. The ECE50 has been designed to be placed on the top of a videoendoscope for the delivery of electrostimulation to the laryngeal region. The stimulation and reaction of the muscles can provide information about the presence and type of dysfunctions and thus influence the treatment procedure. Being a registry a collection of records generated within routine medical procedures with a medical device approved for the EU market, it does not pose additional risks for the patients participating in it.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Legal adults (i.e., as a general rule patients ≥ 18 years old)
- •Legal adults requiring a diagnosis for a disorder that could be traced back to uni- or bilateral dysfunction of one or more laryngeal muscle(s) of the posterior cricoid region
- •Signed and dated informed consent before the start of any registry-specific procedure for all the recruited subjects
排除标准
- •Lack of compliance with any inclusion criteria
- •Use of an active medical implant
- •Known allergies or intolerance to the material used for this registry
- •Parallel participation in a device/drug registry in the period of data collection, which could confound the results of the registry
- •Anything that, in the opinion of the Registry Responsible, would place the subject at increased risk or preclude the subject's full compliance with the general requirements of this registry
结局指标
主要结局
Confirm the safety
时间窗: Immediately after the intervention
Adverse event report analysis
Assess the performance of the ECE50
时间窗: During the intervention
Comparison between the result of the ECE50 stimulation, Laryngeal Electromyography (LEMG), videolaryngoscopy
次要结局
- Standardize the medical procedure for the ECE50(Immediately after the intervention)