Safety and Effectiveness Evaluation of the Sinusway™ Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses in Conjunction With Sinus Balloon Dilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 4
- 主要终点
- Number of Adverse Device Effects
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 access and visualization of the nasal anatomy and paranasal sinuses (Maxillary, Frontal and Sphenoid sinuses) in conjunction with Balloon Sinus Dilation in patients suffering from symptoms attributable to sinusitis is feasible in the office and operating room settings; This is an essential step in the development of a combined dilation and visualization system that will allow visualization, dilation and lavage of the sinuses via their natural ostia during an office visit, and minimize 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient indicated for balloon sinus dilation procedure by the ENT specialist
- •Patient age: adult (>18 years old)
- •Patients in general good health in the opinion of the investigator as determined by medical history and 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
- •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)
结局指标
主要结局
Number of Adverse Device Effects
时间窗: 4 hours
Number of Adverse Device Effects is expected to be similar to the number reported in literature for Nasal Endoscopy
次要结局
- User Satisfaction (1-bad, 5-good)(1 hour)
- Percent of Sinuses Accessed and Visualized Successfully(1 hour)