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Tissue Sensor for Semirigid Thulium Fiber Laser Ureterolithotripsy
Sponsor: Botkin Hospital
Summary
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.
Official title: Tissue Sensor to Reduce Laser-Induced Ureteral Injury During Semirigid Thulium Fiber Laser Ureterolithotripsy: The TISSUE Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
121
Start Date
2026-10-01
Completion Date
2028-11-02
Last Updated
2026-09-22
Healthy Volunteers
No
Conditions
Interventions
Semirigid TFL ureterolithotripsy 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
Semirigid TFL ureterolithotripsy 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.