A Prospective, Multi-center, Single-arm Study to Evaluate the Safety and Efficacy of LithoVue Ureteroscope System in Chinese Patients With Urinary Disease(LithoVue China Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 3
- 主要终点
- Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From Procedure
研究概览
简要总结
To evaluate the safety and efficacy of LithoVue ureteroscope system in Chinese population.
详细描述
This is a prospective, multicenter, single-arm, pre-market study.The aim of this study is to evaluate the safety and efficacy of LithoVue ureteroscope system in Chinese population, to support the regulatory approval by CFDA. The study will enroll 60 patients in 3 investigational sites in China. The primary endpoint is procedure success rate of LithoVue ureteroscope system, the procedure success is defined as:Scope condition is suitable to complete the procedure and not requiring immediate scope substitution; it is also considered as a procedure success if the clinical effect is the same as that from the LithoVue scope per investigator's judgement in the case of a scope change (non-LithoVue).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide written informed consent to participate in the study
- •Willing and able to comply with the study procedures
- •Diagnosed as urinary disease and indicated for flexible ureteroscope procedure
- •For stone cases, the diameter of stones is less than or equal to 2cm in order to avoid staged procedures
排除标准
- •Surgeries are contraindicated
- •Flexible ureterocope procedure is contraindicated
- •Based on doctor's evaluation, the patient's medical condition doesn't fit for this study
- •For stone cases, the diameter of stones is greater than 2cm
- •Women of childbearing potential who are or might be pregnant at the time of this study
结局指标
主要结局
Procedure Success Rate of LithoVue Ureteroscope System at 4Weeks4Weeks ± 7 Days From Procedure
时间窗: 4Weeks ± 7 days from procedure
Procedure success is defined as: Scope condition is suitable to complete the procedure and not requiring immediate scope substitution; it is also considered as a procedure success if the clinical effect is the same as that from the LithoVue scope per investigator's judgement in the case of a scope change (non-LithoVue).
次要结局
未报告次要终点