Outcomes of Using FANS With FURS in TTT of Lower Calyceal Stones.

Condition(s) studied

Investigational drug(s) / intervention(s)

flexible and navigable suction sheath with flexible ureteroscopy: placement of flexible and navigable suction sheath (FANS)which has an oblique side branch with pressure vent, that can be connected to negative pressure aspiration, and a flexible tip, allowing for efficient and effective treatment of urinary stones. * Flexible URS diameter will be at the least 2 Fr smaller than the sheath. * The main tube is closed by a rubber seal with a center aperture as the flexible ureteroscope pathway, The oblique tube with a pressure-regulating venting slit along the longitudinal axis acts as a suctioning channel connected to a vacuum device. * The inflow of irrigation is through the endoscope, the outflow of irrigation is between the scope and the sheath. * A vortex is created at the distal end of the sheath, the irrigation fluid, the stone fragments, dust, and blood, etc. in the vortex can be aspirated out. * The aspiration pressure can be adjusted by the pressure vent on the oblique side branch of the sheath.

Study summary

The aim of this study is to evaluate and assess the outcomes of flexible ureteroscopy (FURS) with flexible and navigable suction UAS (FANS) in the treatment of lower calyceal stones.

Eligibility

Primary outcome measure(s)

• Evaluation of Stone-Free Rate Following Flexible Ureteroscopy with FANS sheath for Management of Renal and Ureteral Calculi. — 1 month after the procedure (preferred and most common for SFR assessment)
  This clinical study aims to evaluate the stone-free rate (SFR) following flexible ureteroscopy (FURS) in patients with renal or ureteral calculi. The primary outcome measure is the proportion of patients who achieve complete stone clearance, as determined by postoperative imaging (non-contrast CT or ultrasound) within a defined follow-up period.

Trial sites (1)

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