LithoVue Elite (LVE) Registry
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint
研究概览
简要总结
To obtain postmarket safety and efficacy data on Boston Scientific LithoVue™ Elite System.
详细描述
LithoVue Elite Registry is a post-market, multi-center, open label, non-randomized, prospective study to document the safety and efficacy data on Boston Scientific LithoVue™ Elite System.
LithoVue Elite System, includes the StoneSmart™ Connect Console (reusable capital/workstation) and a single-use, disposable ureteroscope device.
The LithoVue Elite System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes. It can also be used in conjunction with endoscopic accessories to perform various diagnostic and therapeutic procedures in the urinary tract.
This is a post-market registry study. Any subject who meets eligibility criteria, intends to undergo a diagnostic and/or therapeutic procedure utilizing the LithoVue Elite System, and is willing to provide written informed consent, will be approached and considered for enrollment in the study. Data from diagnostic/therapeutic ureteroscopy procedure and standard of care post-ureteroscopy follow-up visits will be collected. These standard of care follow-up visits are expected to be scheduled within 120 days of the ureteroscopic procedure.
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
- •Subject intends to undergo diagnostic and/or therapeutic procedure in the urinary tract with Boston Scientific LithoVue Elite System
- •Subject is able to accurately detect and report pain
- •Subject is willing and able to complete subject questionnaire at specified time points
- •Subject is willing and able to return for all follow-up visits
排除标准
- •Subject meets any of the contraindications per LithoVue Elite System Instructions/Directions for Use (IFU/DFU)
- •Subject meets any of the contraindications per any accessory devices that will be used in the ureteroscopy procedure
- •Investigator deems subject not suitable for the study
结局指标
主要结局
Occurrence of Serious Adverse Device Effects - Primary Safety Endpoint
时间窗: Up to 120 days of follow up
Primary safety end point is the occurrence of Serious Adverse Device Effects (SADE) related to the LithoVue Elite System including, but not limited to urinary tract perforation and ureteral avulsion
Technical Success using LithoVue Elite System - Primary Effectiveness Endpoint
时间窗: Procedure
Primary effectiveness endpoint is the technical success using LithoVue Elite System, defined as: * Scope allows access to intended urinary anatomy (including utilization of active deflection and guidewire or access sheath) * Scope allows diagnostic and therapeutic tools, as identified in product labelling, to be utilized at target area, if applicable * Scope provides sufficient imaging for target visualization, (stone, calyx, etc.) * Scope provides real-time urinary system pressure measurements at target sites, if applicable Tool used will be a yes or no question on the case report form
次要结局
- Occurrence of Procedure-Related Adverse Events and/or Adverse Device Effects Related to the LithoVue Elite System - Secondary Safety Endpoint(Up to 120 days of follow up)