NCT02673944已完成不适用
An Accuracy Study to Assess the Performance of the Peritron+ in Measuring Vesical Pressure in Patients in Comparison With Standard Urodynamic Measurements
Laborie Medical Technologies Inc.0 个研究点目标入组 10 人开始时间: 2016年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 主要终点
- Accurate Vesical PRessure
研究概览
简要总结
A comparative study will be conducted and the patient will undergo a conventional urodynamic study. In order to successfully determine if the Peritron+ is capturing vesical pressure measurements consistent with conventional urodynamics the two sources of Pves will be collected concurrently.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients normally indicated for urodynamic evaluation
排除标准
- •Patients who suffer from bladder infections
- •Patients who suffer from strictures in the urethra
结局指标
主要结局
Accurate Vesical PRessure
时间窗: During a routine urodynamic study (1 hr approx)
To validate that the Peritron+ digital readings are identical to the urodynamic readings (+/- 3 cm H2O) in the sitting position.
次要结局
未报告次要终点
研究者
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