Steerable vs Conventional FANS for <2cm Lower Pole Stone Treatment: SCULPT Trial

Condition(s) studied

Investigational drug(s) / intervention(s)

Steerable FANS: This device is designed for flexible ureteroscopy procedures in patients with lower pole renal stones ≤2 cm. It features an active deflection mechanism that enables independent adjustment to enhance access into the lower pole calyx. The description focuses solely on the device and does not include procedural details already provided in the arm description.

Conventional FANS: This device is intended for use in flexible ureteroscopy for lower pole renal stone management. It relies on passive deflection provided by the flexible ureteroscope for navigation into the lower pole calyx. The description is limited to the device characteristics without duplicating procedural details from the arm description.

Study summary

This multicenter, randomized, controlled superiority trial (the SCULPT trial) aims to compare the efficacy and safety of a novel steerable flexible and navigable suction ureteral access sheath (FANS) versus the conventional FANS in the treatment of lower pole renal stones ≤2 cm. Lower pole stones are particularly challenging due to the narrow infundibular-pelvic anatomy that limits the maneuverability of standard FANS. The steerable FANS incorporates an active deflection mechanism that allows for independent control, potentially improving the success rate of accessing the lower pole calyx, performing laser lithotripsy, and aspirating stone fragments without additional adjuncts.

A total of 400 patients from 20 high-volume urological centers in China (approximately 20 patients per center) will be randomized in a 1:1 ratio to receive either steerable FANS or conventional FANS during flexible ureteroscopy. Primary outcome measures include the success rate of FANS navigation into the lower pole calyx as evidenced by direct stone visualization, effective laser lithotripsy, and successful stone aspiration. Secondary outcomes will assess immediate and 1-month stone-free rates, operative time, complication rates, instrument durability, and improvements in quality of life. This study is expected to provide critical evidence to guide clinical decision-making and potentially improve treatment efficiency for challenging lower pole renal stones.

Eligibility

Primary outcome measure(s)

• Success Rate of Lower Pole Navigation — Periprocedural (Day of Procedure)
  This outcome is defined as the proportion of cases in which the FANS (either steerable or conventional) successfully navigates into the lower pole renal calyx. Success is evidenced by the ability to directly visualize the stone, perform effective laser lithotripsy, and aspirate stone fragments without requiring additional adjunctive devices.

Trial sites (1)

More The First Affiliated Hospital of Guangzhou Medical University trials in China

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