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

Recruiting now · Not applicable

Conditions studied: Nephrolithiasis

In brief

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.

Key facts

Study ID

NCT07058402

Run by

Changhai Hospital

People needed

308

Starts

2025-04-01

Expected to finish

2026-06-30

Last updated by the study team

2025-07-10

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 and 80 years
• American Society of Anesthesiologists (ASA) physical status classification of I-III
• Single renal stone with a diameter between 2-3 cm confirmed by non-contrast CT scan
• Signed written informed consent and willingness to comply with study procedures

You may not qualify if…

• Anatomical abnormalities of the urinary tract (e.g., horseshoe kidney, ileal conduit)
• Uncontrolled urinary tract infection
• Absolute contraindications for RIRS or PCNL
• Inability to understand or complete study documentation
• Failure to follow study protocol or attend follow-up
• Patients requiring urgent rescue or at high risk for irreversible harm during surgery
• Patients who voluntarily withdraw from the study

Where it is running

• Changhai Hospital, Naval Medical University — Shanghai, Shanghai Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.