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

NARecruitingINTERVENTIONAL
Enrollment

308

Participants

Timeline

Start Date

April 1, 2025

Primary Completion Date

April 30, 2026

Study Completion Date

June 30, 2026

Conditions
Nephrolithiasis
Interventions
PROCEDURE

Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath

Participants undergo retrograde intrarenal surgery (RIRS) using a tip-flexible suction access sheath. The procedure involves the insertion of a flexible ureteroscope through the urethra and ureter into the kidney. A novel access sheath with tip-flexible and suction capabilities is used to facilitate stone fragmentation and removal. The goal is to improve stone clearance and reduce intrarenal pressure during the procedure.

PROCEDURE

Standard Percutaneous Nephrolithotomy (PCNL)

Participants undergo standard percutaneous nephrolithotomy (PCNL). The procedure involves creating a percutaneous tract into the renal collecting system under imaging guidance, followed by nephroscope insertion to fragment and extract 2-3 cm renal stones. This represents the current standard of care for large renal calculi.

Trial Locations (1)

200433

RECRUITING

Changhai Hospital, Naval Medical University, Shanghai

All Listed Sponsors
collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

collaborator

Zhejiang Provincial People's Hospital

OTHER

collaborator

Affiliated Hospital of Jiaxing University

OTHER

lead

Changhai Hospital

OTHER