NCT06996587招募中不适用
A Randomized Controlled Trial Comparing Efficacy, Ergonomics, and Safety of ILY Robotic System vs Manual Flexible Ureteroscopy in Patients Undergoing Laser Lithotripsy for Kidney Stones
Albert El Hajj1 个研究点 分布在 1 个国家目标入组 152 人开始时间: 2025年5月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Efficacy assessed by measuring the stone-free rate (SFR)
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy, ergonomics, and safety of robotic versus manual flexible ureteroscopy (fURS) for kidney stone treatment in adult patients undergoing laser lithotripsy.
- Does robotic-assisted lithotripsy using the ILY® robot have the same efficacy as the manual fURS in treating kidney stones?
- Is robotic flexible ureteroscopy associated with similar or improved safety outcomes, including perioperative and 30-day postoperative complication rates?
- Does the robotic system offer improved ergonomics, lower surgeon radiation exposure, and favorable intraoperative metrics compared to manual flexible ureteroscopy? Researchers will compare the ILY robotic system with manual fURS to see if robotic intervention can match or improve clinical and ergonomic outcomes.
Participants will:
- Be randomly assigned to undergo laser lithotripsy with either the ILY robot or manual flexible ureteroscopy
- Complete standard pre- and postoperative assessments
- Undergo evaluation for stone-free status using a non-contrast CT scan at 30 days postoperatively
- Undergo evaluation for postoperative complications
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females ≥ 18 years old
- •Patients with a normal pelvicalyceal anatomy
- •Patients with renal stone diagnosis confirmed by noncontrast computed tomography regardless of stone size, location, and multiplicity
- •ASA score I-III
- •Intact mental and cognitive ability to provide informed consent and willingness to participate in the study with 30-day follow-up
排除标准
- •Children < 18 and pregnant women
- •Patients with anatomically anomalous kidneys, known case of stricture or stenosis, or recent 3-month history of ureteroscopy (DJ stent placement only will be accepted) or known history of complicated ureteroscopy
- •Patients in whom stone measurement was not feasible on NCCT or those with concomitant ureteric stones.
- •ASA score IV
- •Mentally incapacitated patients unable to provide informed consent
研究组 & 干预措施
Robotic-Assisted fURS Group using the ILY Robot
Experimental
Participants undergo flexible ureteroscopy using the ILY® robotic system.
干预措施: Robotic-Assisted Flexible Ureteroscopy (Procedure)
Manual fURS Group
Active Comparator
Participants undergo standard manual flexible ureteroscopy.
干预措施: Manual Flexible Ureteroscopy (Procedure)
结局指标
主要结局
Efficacy assessed by measuring the stone-free rate (SFR)
时间窗: 30 days after the index procedure
A patient is considered stone free if there are no visible residual stone fragments after the treatment.
次要结局
- Ergonomics(Immediately after the procedure)
- Intraoperative Parameters(During the procedure)
- Perioperative and 30-day Postoperative Outcomes(Perioperatively and 30 days after the procedure)
- Surgeon safety in terms of radiation exposure(During the procedure)
- Conversion rate(During the procedure)
研究者
Albert El Hajj
Associate Professor of Urology
American University of Beirut Medical Center
研究点 (1)
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