Treatment of Upper Urinary Tract Stones With a Diameter≤2cm by Intelligent Pressure-controlled Fl… (NCT05201599) | Clinical Trial Compass
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Treatment of Upper Urinary Tract Stones With a Diameter≤2cm by Intelligent Pressure-controlled Flexible Ureteroscope
China449 participantsStarted 2021-08-11
Plain-language summary
The aim of this trial is to compare the efficacy and safety of flexible ureteroscope with intelligent control of renal pelvic pressure (FURL-ICP) and traditional flexible ureteroscope(f-URL) in the treatment of upper urinary stones ≤ 2cm in diameter. It is designed as a multicenter, parallel randomized controlled trial with two arms. At least 449 patients with upper urinary stones ≤ 2cm in diameter will be invited to participant in this study. Patients will be assigned to intervention group (FURL-ICP group) or control group (f-URL) by a simple random sampling technique with a rate of 1:1. The baseline of participants include demographic data, urine analysis, blood cell analysis, blood biochemical analysis, and urinary computer tomography (CT) with a slice thickness of 2mm. The primary outcomes are postoperative stone-free rate (SFR) of one month by CT scan and postoperative fever rate (body temperature \> 38.5 ℃ within 3 days after operation). Secondary outcomes include operating time, degree of ureteral injury, SFR of one day.
Who can participate
Age range
18 Years – 70 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:
* The diameter of single stone or cumulative maximum diameter for multiple stones is less than or equal to 2cm
* American Society of Anesthesiology scores of 1to 2
* All patients participate in this study voluntarily and signed informed consent
Exclusion Criteria:
* Uncontrolled urinary tract infection
* Patients with pyonephrosis are found during operation
* The patients with abnormal anatomy (heterotopic kidney, horseshoe kidney, duplicate kidney), ureteral stricture, urethral stricture and urinary diversion
* Severe hydronephrosis
* Renal function was decompensated (serum creatinine \> 178 μmol/L)
* Severe systemic hemorrhagic disease
* Patients who underwent bilateral surgery at the same time
* Severe deformity of hip joint and difficult position
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.