Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 3
- 主要终点
- Safety assessed by unanticipated device-related adverse events
研究概览
简要总结
3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.
详细描述
The rationale behind this feasibility study is to show that accessing and visualization of the nasal anatomy and paranasal sinuses (Maxillary, Frontal and Sphenoid sinuses) in patients suffering from symptoms attributable to sinusitis is feasible; This is an essential step in the development of a system that will later allow visualization, sampling, and treatment of the sinuses via the natural sinus ostium during the patient's first office visit in a minimally invasive manner while enabling treatment by lavage, and minimizing radiation exposure, antibiotic use, multiple office visits, and cost.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient indicated for primary FESS procedure by the ear, nose and throat (ENT) specialist
- •Patient age: adult (>18 years old)
- •Patients in general good health in the opinion of the investigator as determined by medical history physical examination
- •A patient who is able to understand the requirements of the study, is willing to comply with its instructions and schedules, and agrees to sign the informed consent
排除标准
- •A patient with nasal polyposis
- •A patient indicated for tumor excision
- •Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation
- •Patients with known current or previous bleeding disorder receiving anticoagulants (e.g., chronic Coumadin treatment)
- •Pregnancy
- •Patients with previous FESS surgery
研究组 & 干预措施
3NT flexible endoscope
Evaluation of 3NT flexible endoscope in terms of access and evaluation of the nasal anatomy
干预措施: 3NT flexible endoscope (Device)
结局指标
主要结局
Safety assessed by unanticipated device-related adverse events
时间窗: During hospital stay, up to 1 day
次要结局
- Performance assessed by anatomical landmarks reached and visualized will be recorded(During procedure, up to 3 hours)