Assessing the Performance, Safety and Usability of Our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults.
研究概览
简要总结
Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and Female (Adult age 21+)
- •Patients with clinical indication for urodynamics (UDS) testing, for any medically necessary reason as per the physician.
排除标准
- •Patients who suffer from bladder infections (not including patients with asymptomatic bacteriuria)
- •Patients who are pregnant
- •Patients with recent (less than 2 weeks) pelvic floor surgery
- •Patients who require the use of a suprapubic catheter
- •Patients with significant cognitive deficiency that prevent the patient from giving informed consent
结局指标
主要结局
The Number of Patients in Which the T-DOC® NXT Catheters Are Safe in Measuring Urodynamic Pressure in Adults.
时间窗: 2 months
A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where safety (Yes the device is safe and No the device is not safe) will be reported. A minimum of 20 patient questionnaires is required to answer "YES" the device is safe for a positive outcome and a maximum of 40.
The Number of Patients in Which the T-DOC® NXT Catheters Are Effective in Measuring Urodynamic Pressure in Adults.
时间窗: 2 months
A binary clinician response after each UDS study is used to assess if it is clinically adequate (success) or inadequate (failure) in each patients questionnaire and presented to the clinician where effectiveness (Yes the device is effective and No the device is not effective) will be reported. A minimum of 20 patient questionnaires is required to answer "YES" the device is effective for a positive outcome and a maximum of 40.
次要结局
未报告次要终点