NCT06898216 Steerable vs Conventional FANS for <2cm Lower Pole Stone Treatment: SCULPT Trial
| NCT ID | NCT06898216 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The First Affiliated Hospital of Guangzhou Medical University |
| Condition | Kidney Stones |
| Study Type | INTERVENTIONAL |
| Enrollment | 400 participants |
| Start Date | 2025-03-16 |
| Primary Completion | 2026-01-01 |
Trial Parameters
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Brief 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 Criteria
Inclusion Criteria: * Adults aged 18-75 years * Diagnosed with a single lower pole renal stone ≤2 cm by CT * American Society of Anesthesiology (ASA) score of 1-3 * Ability to provide written informed consent * Willingness and ability to comply with trial procedures and follow-up Exclusion Criteria: * Patients with urinary tract anatomical abnormalities (e.g., horseshoe kidney, ileal conduit) * Untreated urinary tract infection * Presence of multiple stones or stones located outside the lower pole * Absolute contraindications to flexible ureteroscopy * Inability to understand or complete trial documentation
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