Tissue Sensor for Semirigid Thulium Fiber Laser Ureterolithotripsy
ConditionNephrolithiasis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBotkin Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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.
Disqualifiers
• 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Semirigid TFL ureterolithotripsy with Tissue Sensor activated.
Procedure/SurgerySemirigid 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.
Procedure/SurgerySemirigid 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.
Treatment groups
121 Participants
are divided into 2 treatment groupsGroup A: Patients after ureterolithotrypsy with Tissue Sensor activatedExperimental treatment 1 intervention
Group B: Patients after ureterolithotrypsy with Tissue Sensor deactivatedExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of intraoperative laser-induced injury to the ureteral mucosa
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.
Time frame
intraoperativeSecondary outcomes
1
Incidence of postoperative ureteral stricture
Incidence of postoperative ureteral stricture detected during the 12 months after the intervention. * Stone-free rate on low-dose non-contrast CT at 1 month. * Incidence and total number of Tissue Sensor trigger events in the TS group. * Incidence and total number of visually confirmed contacts between an activated laser fiber and the mucosa in the control group. * Number of trigger events or contacts per minute of laser activation. * Severity of mucosal injury according to the standardized scale. * Total operative time. * Lithotripsy time. * Cumulative laser activation time. * Migration of the stone or fragments into the kidney. * Need for conversion to flexible ureteroscopy or repeat intervention. * Type and duration of postoperative drainage. * Postoperative complications according to the Clavien-Dindo classification. * New or progressive hydronephrosis during follow-up.
Time frame
12 months.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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