NCT05835323已完成不适用
Initial Experience of the Treatment of Kidney Stones With the MONARCH™ Platform, Urology
适应症
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
- Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure.
研究概览
简要总结
The purpose of this study is to collect descriptive performance data using the MONARCH Platform, Urology (a novel robotic device) to perform mini-percutaneous nephrolithotomy (kidney stone removal) procedures. Data gathered from this study will be used to optimize the robotic platform and inform training and education material for the future users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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), greater than or equal to (>=) 10 millimeter in size identified on computerized tomography (CT) scan, and appropriate for Percutaneous nephrolithotomy (PCNL) treatment according to American Urological Association (AUA) guidelines
- •Normal upper tract anatomy, amenable to PCNL and ureteroscopy
- •Body mass index less than (<) 40 kilogram-meter squared
- •Participants with a percutaneous tract length <15 centimeter 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
- •Pre-Operative
排除标准
- •Any medical or physical condition/limitation that would contraindicate a conventional ureteroscopy or PCNL [for example, atypical interposition of visceral organs (bowel, spleen, or liver)] in the supine position. This assessment will be made by the investigator team
- •Participation in any other clinical trial 30-days before and throughout the duration of the study that might impact the results
- •A solitary functioning kidney
- •Female subjects who are pregnant or nursing or those of childbearing potential refusing a pregnancy test
- •Presence of ureteral impacted stones
- •Presence of ureteral obstruction
- •Presence of untreated urinary tract infection, urosepsis
- •Inability to give consent
- •Presence of a renal mass which has not been investigated
- •Staghorn stone
- •Participant has an electrically or magnetically activated implanted medical device
- •Significant pharmacological anticoagulant therapy or uncorrected bleeding diathesis
- •Tumor in the probable access tract area and potential malignant renal tumor
- •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. For example, participants no longer considered good candidates for a mini-PCNL procedure for the removal of the kidney stones.
结局指标
主要结局
Completion of the Robotic Assisted Mini-PCNL Kidney Stone Removal Procedure.
时间窗: Day of Procedure
Percentage of participants in whom the kidney stone treatment and removal procedure could be successfully completed with the MONARCH™ Platform, Urology.
次要结局
未报告次要终点
研究者
研究点 (2)
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