Tissue Sensor to Reduce Laser-Induced Ureteral Injury During Semirigid Thulium Fiber Laser Ureterolithotripsy: The TISSUE Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 121
- 主要终点
- Incidence of intraoperative laser-induced injury to the ureteral mucosa
研究概览
简要总结
Tissue Sensor (TS) is a technology designed to automatically deactivate laser emission when contact between the laser fiber and tissue is detected. It is hypothesized that the use of TS during contact laser ureterolithotripsy may reduce unintended laser exposure of the ureteral mucosa, thereby decreasing the risk of immediate thermal injury to the ureteral wall and subsequent scar-related narrowing.
To reduce the influence of baseline risk factors for stricture, the study will enroll a homogeneous population of patients without urinary tract anomalies, previous surgery on the study ureter, or impacted stones. The procedure will be performed according to a standardized protocol using a semirigid ureteroscope, a thulium fiber laser, and predefined technical restrictions. The study is limited to patients with stones in the mid or distal ureter. This approach is intended to minimize the likelihood of stone retropulsion into the kidney, standardize the surgical technique, reduce the need for conversion to flexible ureteroscopy, and maximize comparability between the study groups.
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
- None
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
- •• Age 18 years or older.
- •A single stone in the mid or distal ureter.
- •Maximum stone diameter of 15 mm or less on preoperative CT.
- •An indication for elective semirigid laser ureterolithotripsy.
- •Feasibility of performing the procedure with a semirigid ureteroscope.
- •No active urinary tract infection at the time of the intervention.
- •Ability to undergo CT follow-up and complete 12 months of follow-up.
- •Signed written informed consent.
排除标准
- •• Age 18 years or older.
- •A single stone in the mid or distal ureter.
- •Maximum stone diameter of 15 mm or less on preoperative CT.
- •An indication for elective semirigid laser ureterolithotripsy.
- •Feasibility of performing the procedure with a semirigid ureteroscope.
- •No active urinary tract infection at the time of the intervention.
- •Ability to undergo CT follow-up and complete 12 months of follow-up.
- •Signed written informed consent.
研究组 & 干预措施
Patients after ureterolithotrypsy with Tissue Sensor activated
Semirigid TFL ureterolithotripsy will be performed with Tissue Sensor activated. All automatic system trigger events will be recorded by the laser system or in the study case report form and, whenever possible, synchronized with the procedure video recording
干预措施: Semirigid TFL ureterolithotripsy with Tissue Sensor activated. (Procedure)
Patients after ureterolithotrypsy with Tissue Sensor deactivated
Semirigid TFL ureterolithotripsy will be performed with Tissue Sensor deactivated. Visually confirmed contacts between the activated laser fiber and the ureteral mucosa will be recorded from the procedure video
干预措施: Semirigid TFL ureterolithotripsy with Tissue Sensor deactivated. (Procedure)
结局指标
主要结局
Incidence of intraoperative laser-induced injury to the ureteral mucosa
时间窗: intraoperative
Incidence of intraoperative laser-induced injury to the ureteral mucosa, defined as any visible injury compatible with exposure to an activated laser fiber, as determined by independent blinded video assessment.
次要结局
- Incidence of postoperative ureteral stricture(12 months.)
研究者
Malkhasyan Vigen Andreevich
Doctor of medical science
Botkin Hospital