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New treatment option for Nephrolithiasis
Official title RIRS With Flex Suction Sheath vs. PCNL for 2-3 cm Renal Stones
ClinicalTrials.gov ID: NCT07058402
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join 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 likely can't join 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.