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

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.

NCT Number	NCT06898216
Lead Sponsor	The First Affiliated Hospital of Guangzhou Medical University Collaborators: Third Medical Center of Chinese PLA General Hospital, First Affiliated Hospital of Chongqing Medical University, Peking University People's Hospital, The Second Affiliated Hospital of Kunming Medical University, Fifth Affiliated Hospital, Sun Yat-Sen University, Henan Provincial People's Hospital, Nanfang Hospital, Southern Medical University, Wuhan Hospital of Traditional Chinese Medicine, Dongguan People's Hospital, Changzhou No.2 People's Hospital, Dongguan Tungwah Hospital, Panzhihua Central Hospital, Yan'an Affiliated Hospital of Kunming Medical University, NO.1 People's Hospital of Dali City, Huadu District People's Hospital of Guangzhou, Jiangmen Central Hospital, Shaoyang Central Hospital, Guangzhou Medical University Affiliated Qingyuan Hospital, Dongguan Kanghua Hospital
Conditions	Kidney Stones
Enrollment	400 participants
Start Date	2025-03-16
Primary Completion	2026-01-01 (estimated)
Study Completion	2026-03-01 (estimated)
Updated on ClinicalTrials.gov	2025-03-27