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临床试验/NCT07607652
NCT07607652已完成不适用

Development of a Cardiac Signal Analysis Algorithm for Bladder Filling Assessment: Pilot Study

University Hospital, Lille1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月14日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1

研究概览

简要总结

The puropose of this clinical trial is to build a database of signals issued from the device to delvelop signal processing algorithms to calculat the LFVI.

This study will be carried out in the urology department of the Claude Huriez Hospital.

Electrods will be placed on the patient body to capture the ECG during the urodynmic evaluation.

The recording of the ECG will last fir the duration of the evaluation. This procedure will not affect the usual care of the patient

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • patient undergoing urodynamic testing for pure stress urinary incontinence caused by urethral hypermobility

排除标准

  • Urge urinary incontinence or mixed urinary incontinence
  • Bladder emptying disorder
  • Bladder sensory disorder
  • History of pelvic surgery
  • History of perineal surgery
  • History of spinal surgery
  • Neurological condition / dysfunction
  • Subjects with an implanted medical device (pacemaker, etc.)
  • Allergy to a component of the PC-ECG 1200 device (Norav medical ®)

研究者

发起方
University Hospital, Lille
申办方类型
Other
责任方
Sponsor

研究点 (1)

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