Tissue Sensor for Semirigid Thulium Fiber Laser Ureterolithotripsy

N/ANot Yet RecruitingNCT07835113

Botkin Hospital121 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

121

Conditions

Nephrolithiasis

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * • 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. Exclusion Criteria: * • 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.

Outcomes

Primary Outcomes

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: intraoperative

Secondary Outcomes

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.