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

RecruitingNAAges 18 Years - 80 YearsAllChanghai Hospital
NCT07058402 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: 1. Age between 18 and 80 years 2. American Society of Anesthesiologists (ASA) physical status classification of I-III 3. Single renal stone with a diameter between 2-3 cm confirmed by non-contrast CT scan 4. Signed written informed consent and willingness to comply with study procedures Exclusion Criteria: 1. Anatomical abnormalities of the urinary tract (e.g., horseshoe kidney, ileal conduit) 2. Uncontrolled urinary tract infection 3. Absolute contraindications for RIRS or PCNL 4. Inability to understand or complete study documentation 5. Failure to follow study protocol or attend follow-up 6. Patients requiring urgent rescue or at high risk for irreversible harm during surgery 7. Patients who voluntarily withdraw from the study
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What it tests

  • Retrograde Intrarenal Surgery (RIRS) with Tip-Flexible Suction Access Sheath
  • Standard Percutaneous Nephrolithotomy (PCNL)
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Where

1 site
Changhai Hospital, Naval Medical University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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