Post-Operative Outcomes Following the Treatment of Kidney Stones With the MONARCH Platform, Urology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure
研究概览
简要总结
The purpose of the study is to assess procedural completion, the post-operative stone clearance and the safety profile following robotic mini-Percutaneous Nephrolithotomy (PCNL) performed with the MONARCH Platform, Urology.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Simple renal caliceal and/or pyelo stone(s) with stone burden => 1 cm, identified on CT scan, and appropriate for PCNL treatment according to AUA guidelines
- •Normal upper tract anatomy, amenable to PCNL and ureteroscopy
- •Participants with a percutaneous tract length < 15 cm as measured by the estimation of the skin to stone or skin to appropriate calyx for treatment through a CT scan
- •Participant is an appropriate candidate for a mini-PCNL based on the clinical guidelines and investigator assessment.
排除标准
- •Pre-Procedure:Exclusion Criteria:
- •Any medical or physical condition/limitation that would contra-indicate a conventional ureteroscopy or PCNL in the supine position (e.g., atypical interposition of visceral organs (bowel, spleen, or liver))
- •Expected additional procedure, or participation in any clinical trial, from 30 days prior to the study procedure and throughout the duration of the study, which might impact this study's results
- •A solitary functioning kidney
- •Female participants who are pregnant or nursing or those of child-bearing potential refusing a pregnancy test
- •Presence of ureteral impacted stones
- •Intra-Procedure Exclusion Criteria:
- •- Any presenting condition discovered intra-procedurally that in the opinion of the investigator would make participating in this study not in the participant's best interest.
研究组 & 干预措施
Robotic mini-Percutaneous Nephrolithotomy (PCNL)
Participants with kidney stones will be enrolled for a robotic-assisted mini-percutaneous nephrolithotomy procedure using the MONARCH Platform, Urology for removal of kidney stones. The MONARCH Platform, Urology enables electro-mechanical articulation and precise control of a flexible ureteroscope and/or a flexible mini-PCNL suction catheter ("catheter") for visualization and access to the urinary tract for diagnostic and therapeutic procedures.
干预措施: Robotic-assisted mini-PCNL (Device)
结局指标
主要结局
Percentage of Participants Who Achieved Successful Completion of Robotic-Assisted Combined Intrarenal Surgery (RACIRS) Kidney Stone Removal Procedure
时间窗: On the day of procedure at Day 1
Percentage of participants who achieved successful completion of the RACIRS kidney stone removal procedure were reported. Successful completion of the robotic-assisted kidney stone removal procedure was defined as using robotic-assistance provided by the MONARCH Platform, Urology to achieve the following procedure milestones: (1) gained safe concomitant (that is, retrograde and antegrade) access to the upper urinary tract, (2) located and visualized kidney stones, (3) enabled fragmentation of stones by standard of care method, (4) evacuated stone fragments and dust, and (5) completed treatment without need for case conversion, as assessed by the investigator.
次要结局
- Stone Free Rate(Post-operative Day 30)
- Number of Participants With Adverse Events (AEs)(From the day of procedure (Day 1) up to 90 days post-procedure)
- Percentage of Participants With Procedure Conversions to Conventional Treatment Methods Due to Study Device-related Safety Event(On the day of procedure (Day 1))