NCT06402097已完成不适用
'Transdermal Rigidity Assessment Via Ischemia of the Penis (TRIP). A New Sensor-driven Device to Measure Maximal Rigidity.'
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- change in sensor-readings
研究概览
简要总结
To measure saturation and desaturation of the cavernosal tissue with a cutaneous placed penile sensor, before and during full rigidity. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis
详细描述
To measure saturation and desaturation of the cavernosal tissue with a cutaneous placed penile sensor, before and during full rigidity. To validate discriminating sensor-readings between flaccid state and full rigidity of the penis
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Indication for a penile duplex in our andrology clinic Signed informed consent Male Between 18-60 year
排除标准
- •Patients who are unwilling to sign written informed consent
- •Patients unable to undergo a duplex of the penis
- •Patients with sickle cell anemia because this could affect the accuracy of the measurements
结局指标
主要结局
change in sensor-readings
时间窗: 1 hour
To validate discriminating sensor-readings between flaccid state and full rigidity of the penis
次要结局
未报告次要终点
研究者
Evelien Trip
Study Principal Investigator
St. Antonius Hospital
研究点 (1)
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