Super-Pulsed Thulium Fiber Laser Versus Holmium:YAG Laser in Retrograde Intrarenal Surgery for Upper Ureteral and Renal Stones

The holmium laser is currently considered the gold standard for lithotripsy on urinary lithiasis, whereas the super-pulsed thulium fibre laser is a relatively new technology. Through a multi-center prospective randomised clinical study that mainly aims to explore the effectiveness and safety of a super-pulsed fibre thulium laser compared to a holmium laser in the treatment of upper ureteral and renal stones (10mm\<cumulative maximum diameter ≤ 25mm) in retrograde intrarenal surgery. The research participants are assigned randomly to undergo retrograde intrarenal surgery (RIRS) either using a super-pulsed thulium fibre laser or a holmium-YAG laser with an allocation ratio of 1:1. The secondary aim of this study is to provide high-level evidence for the development of diagnostic and treatment guidelines in the field of urolithiasis, both domestically and internationally. The outcomes of the RIRS procedures are compared for the two treatment arms.

NCT Number	NCT07012941
Lead Sponsor	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Collaborators: RenJi Hospital, Tongji Hospital, West China Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Renmin Hospital of Wuhan University, Beijing Friendship Hospital, Second Affiliated Hospital of Guangzhou Medical University, Beijing Tsinghua Changgeng Hospital, People's Hospital of Guangxi Zhuang Autonomous Region, Peking University Shenzhen Hospital, Shenzhen People's Hospital
Conditions	Ureterolithiasis, Renal Calculi
Enrollment	448 participants
Start Date	2025-07-01
Primary Completion	2027-02-28 (estimated)
Study Completion	2027-03-20 (estimated)
Updated on ClinicalTrials.gov	2025-06-10