NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 163
- 试验地点
- 14
- 主要终点
- Assess NXT system safety
研究概览
简要总结
NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations
详细描述
The primary objective of this study is to confirm the safety and performance of NXT urodynamic system for the intended patient populations, medically indicated for urodynamic study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients medically indicated for urodynamic study
- •Patient or legally authorized representative provides written authorization and/or consent per institution and geographical requirements
排除标准
- •Patients or legally authorized representative with cognitive or psychiatric condition that interferes with or precludes direct and accurate communication regarding the study, giving informed consent or ability to complete the patient questionnaire
- •Patients with confirmed active bladder infections (not including patients with asymptotic bacteria)
- •Pregnant women
- •Patients with recent (less than 2 weeks) pelvic floor surgery
- •Requires use of suprapubic catheter
研究组 & 干预措施
Male Adult Incontinence and/or Overactive Bladder
干预措施: Urodynamic procedure (Diagnostic Test)
Female Adult Incontinence and/or Overactive Bladder
干预措施: Urodynamic procedure (Diagnostic Test)
Adults with Neurological Co-morbidities
Pediatric
干预措施: Urodynamic procedure (Diagnostic Test)
Male Adult Obstructive
Female Adult Obstructive
结局指标
主要结局
Assess NXT system safety
时间窗: 120 Minutes
The primary safety endpoint will be measured by recording the incidence of serious adverse events and adverse events.
Assess NXT system performance
时间窗: 120 Minutes
Assess the proportion of affirmative responses to the question: did the NXT system successfully measure all necessary urodynamic parameters you required for this patient?
次要结局
- Assess NXT system performance(120 Minutes)