RIRS With Flex Suction Sheath vs. PCNL for 2-3 cm Renal Stones (NCT07058402) | Clinical Trial Compass
RecruitingNot Applicable
RIRS With Flex Suction Sheath vs. PCNL for 2-3 cm Renal Stones
China308 participantsStarted 2025-04-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Exclusion criteria
. Anatomical abnormalities of the urinary tract (e.g., horseshoe kidney, ileal conduit)
. Uncontrolled urinary tract infection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.