Prospective Multi-center Study Comparing Pulsed Tm:YAG Laser to Pulse Modulated Holmium Laser in the Treatment of Nephrolithiasis With Flexible And Navigable Ureteric Access Sheath (FANS)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Stone-free rate (absence of any fragments ≥ 2mm)
研究概览
简要总结
The purpose of this study is to compare two laser technologies that are routinely used during ureteroscopy for the treatment of kidney stones. Specifically, this study will compare a pulsed Thulium:YAG laser to a pulse-modulated Holmium:YAG laser (Moses technology) to evaluate how effective and safe they are when used to break kidney stones.
Primary endpoints include stone-free rate and the zero stone-free rate at a standardized postoperative. Secondary endpoints include total operative time, lasing time (s), laser energy expended (J), efficiency (laser energy expended/stone volume; stone volume/lasing time). These endpoints aim to provide a comprehensive assessment of the clinical effectiveness and procedural efficiency of the two laser systems.
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)
盲法说明
The case coordinator will inform the operating surgeon of the assigned laser before the procedure begins. Study participants will remain blinded to the laser assignment. Outcome assessments, including imaging based evaluation, will be performed by personnel who are blinded to treatment allocation.
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
- •Solitary renal stone 7 to 20 mm in size or in the case of multiple stones the conglomerate diameter (additive maximal diameter of all stones on axial imaging of computed tomography) of 7-20 mm is required
- •Must be a suitable operative candidate for flexible ureteroscopy per American Urological Association guidelines
- •Must be 18 years or older
- •Must be able to give consent
- •Bilateral ureteroscopy will be permitted , but only the side(s) where the FANS access sheath was used (per surgeon discretion) will be included in the study, however can include both sides as separate units. Subjects will be enrolled only once in the study. No subject will be enrolled more than a single time. For patients undergoing bilateral ureteroscopy, each kidney will be considered a separate unit for stone-related assessments. Peri-patient measures, such as operative time, will be recorded at the patient level. Bilateral cases will be clearly identified and handled consistently to ensure accurate and appropriate interpretation of study outcomes.
- •Must be a patient of one of the surgeons participating in this study.
排除标准
- •Concomitant stones in the ureter
- •Prior radiotherapy to the abdomen or pelvis
- •Neurogenic bladder or spinal cord injury
- •Pregnancy
- •Untreated urinary tract infection (UTI)
- •Anatomical abnormalities (including, but not limited to, bifid system, pelvic kidney, horseshoe kidney)
- •Prior ipsilateral upper urinary tract reconstructive procedures or history of ipsilateral ureteral stricture
研究组 & 干预措施
Pulsed Thulium:YAG laser
Flexible Ureterorenoscopy (URS) for kidney stone treatment will be performed per standard medical care, and surgeons will use the Pulsed Thulium:YAG laser during the procedure.
干预措施: Thulium:YAG laser (Device)
Pulse-modulated Holmium:YAG laser
Flexible Ureterorenoscopy (URS) will be performed using standard techniques without deviation from routine care, and surgeons will use the pulse-modulated Holmium:YAG laser during the procedure.
干预措施: Moses Holmium:YAG laser (Device)
结局指标
主要结局
Stone-free rate (absence of any fragments ≥ 2mm)
时间窗: Month 1
Zero stone-free rate (absence of any residual fragments confirmed by negative CT scan postoperative at one month)
时间窗: Month 1
次要结局
- Total operative time(From first insertion of instruments to final removal of all instruments (up to 3 hours))
- Lasing time(From start of lasing to end of lasing (up to 1 hour))
- Laser energy expended (J)(From start of lasing to end of lasing (up to 1 hour))
- Laser energy expended per stone volume(From start of lasing to end of lasing (up to 1 hour))
- Stone volume per lasing time(From start of lasing to end of lasing (up to 1 hour))