FANS-Assisted Mini-PCNL for Complex Renal Stones

This prospective pilot study aims to evaluate the feasibility, safety, and preliminary clinical outcomes of a novel mini-percutaneous nephrolithotomy (mini-PCNL) technique integrating a flexible mini-nephroscope with a flexible and navigable suction access sheath (FANS) for the treatment of complex renal stones. Thirty consecutive patients with renal stones ≥2 cm will be prospectively enrolled. All patients will undergo FANS-assisted mini-PCNL. The primary outcome is the immediate stone-free rate assessed by non-contrast CT within 72 hours after surgery. Secondary outcomes include operative parameters, postoperative pain, complications, length of hospital stay, and quality of life. This pilot study is designed to provide preliminary evidence supporting the feasibility and safety of FANS-assisted mini-PCNL and to inform the design of future larger-scale studies.

NCT Number	NCT07332286
Lead Sponsor	The First Affiliated Hospital of Guangzhou Medical University
Conditions	Kidney Stones
Enrollment	30 participants
Start Date	2025-12-19
Primary Completion	2026-04-12 (estimated)
Study Completion	2026-04-30 (estimated)
Updated on ClinicalTrials.gov	2026-04-15