Status:
RECRUITING
Steerable vs Conventional FANS for <2cm Lower Pole Stone Treatment: SCULPT Trial
Lead Sponsor:
The First Affiliated Hospital of Guangzhou Medical University
Collaborating Sponsors:
the third Medical Center, PLA General Hospital
First Affiliated Hospital of Chongqing Medical University
Conditions:
Kidney Stones
Eligibility:
All Genders
18-75 years
Phase:
NA
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) ...
Detailed Description
This trial is designed in response to the current challenges faced in the management of lower pole renal stones using flexible ureteroscopy, particularly when using conventional FANS. The narrow calyc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06898216
Start Date
March 16 2025
End Date
March 1 2026
Last Update
March 27 2025
Active Locations (1)
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1
Department of Urology, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510230