试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Lahey Clinic
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Time, ease and accuracy of placement - compare accuracy of trans-illumination with fluoroscopy
研究概览
简要总结
This pilot study will evaluate the accuracy and ease of use of the LUMA light wire and whether trans-illumination of the sinuses is comparable to fluoroscopy during balloon dilation procedures.
详细描述
50 patients undergoing functional endoscopic with balloon dilatation sinus surgery will be studied using the light wire technology. This will be used as a guide for the surgeon to know when they are safely in the sinus by trans-illumination through the sinus wall prior to utilizing balloon dilation. Routine fluoroscopy will be used as well to verify the position of the wire, which is currently standard practice. The ease, time required, and accuracy of placement will be recorded for each case and compared to data previously collected when suing standard wire technology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients needing endoscopic sinus surgery
- •initial or previous sinus surgery subject will be included
排除标准
- 未提供
结局指标
主要结局
Time, ease and accuracy of placement - compare accuracy of trans-illumination with fluoroscopy
时间窗: at conclusion of subject enrollment
次要结局
未报告次要终点