Clinical Trial

RIRS With Flex Suction Sheath vs. PCNL for 2-3 cm Renal Stones

Recruiting
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Record status
This record was last updated July 10, 2025 (before its estimated April 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
This is a multicenter, randomized controlled trial comparing retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath with standard percutaneous nephrolithotomy (PCNL) for the treatment of 2-3 cm unilateral renal stones. The aim is to evaluate the clinical efficacy and safety of the novel suction sheath-assisted RIRS compared to standard PCNL in terms of stone-free rate and postoperative complications. A total of 308 patients will be enrolled across four centers in China.
Trial Details
NCT Number NCT07058402
Lead Sponsor Changhai Hospital
Collaborators: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Zhejiang Provincial People's Hospital, Affiliated Hospital of Jiaxing University
Conditions Nephrolithiasis
Enrollment 308 participants
Start Date 2025-04-01
Primary Completion 2026-04-30 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-07-10