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

RecruitingNAAges 18 Years - 75 YearsAllThe First Affiliated Hospital of Guangzhou Medica…
NCT06898216 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 flexib

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📋 Eligibility rules (as published)
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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What it tests

  • Steerable FANS
  • Conventional FANS
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Where

1 site
Department of Urology, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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