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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 400 participants in total. It began in 2025-03-16 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Guohua Zeng, M.D.
PRINCIPAL INVESTIGATOR
The First Affiliated Hospital of Guangzhou Medical University
Frequently Asked Questions
Who can join the NCT06898216 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Kidney Stones. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06898216 currently recruiting?
Yes, NCT06898216 is actively recruiting participants. Contact the research team at gzgyzgh@vip.sina.com for enrollment information.
Where is the NCT06898216 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT06898216 clinical trial?
NCT06898216 is sponsored by The First Affiliated Hospital of Guangzhou Medical University. The principal investigator is Guohua Zeng, M.D. at The First Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 400 participants.
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