An interventional study of Smart Pressure-Controlled Flexible Ureteroscopy and Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy in Kidney Stones, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Treatment
This prospective, multicenter, randomized, non-inferiority controlled trial aims to compare the efficacy and safety of smart pressure-controlled flexible ureteroscopy and flexible ureteroscopy assisted by a distal flexible suction ureteral access sheath in patients with 2-3 cm renal stones. Eligible patients will be randomly assigned to one of the two treatment groups. The primary objective is to determine whether smart pressure-controlled flexible ureteroscopy is non-inferior to the suction sheath-assisted approach in terms of stone-free rate. Secondary outcomes include operative time, postoperative complications, intrarenal pressure-related outcomes, length of hospital stay, and other relevant perioperative parameters. The findings are expected to provide clinical evidence to guide the selection of surgical techniques for patients with 2-3 cm renal stones.
This prospective, multicenter, randomized, non-inferiority controlled trial will evaluate the efficacy and safety of smart pressure-controlled flexible ureteroscopy compared with flexible ureteroscopy assisted by a distal flexible suction ureteral access sheath in patients with renal stones measuring 2-3 cm.
Eligible patients will be enrolled at participating centers and randomly assigned to one of two treatment groups. The intervention group will undergo flexible ureteroscopy using a smart pressure-control system, while the control group will undergo flexible ureteroscopy assisted by a distal flexible suction ureteral access sheath. Surgical procedures will be performed according to standardized protocols and the applicable instructions for use of the devices.
The primary outcome will be the stone-free rate, assessed using postoperative imaging at a prespecified follow-up time point. Secondary outcomes will include operative time, postoperative complications, changes in renal function where applicable, length of hospital stay, and other perioperative outcomes. Safety assessments will focus on intraoperative and postoperative adverse events, including infectious complications and ureteral injury.
The study will use a non-inferiority design to determine whether smart pressure-controlled flexible ureteroscopy achieves stone clearance outcomes that are not unacceptably worse than those of the distal flexible suction ureteral access sheath-assisted approach, while also evaluating comparative safety. The study results are expected to provide evidence to inform the choice of surgical technique for patients with 2-3 cm renal stones.
509 studies on the registry are indexed under Kidney Calculi; 146 are open to participants now.
This study's planned enrollment of 750 is above the median of 86 across 391 interventional studies indexed under Kidney Calculi.
Browse Kidney Calculi studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 167 studies on the registry; 69 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo flexible ureteroscopy using a smart pressure-control system for the treatment of 2-3 cm renal stones, according to the study protocol and device instructions for use.
Device: Smart Pressure-Controlled Flexible Ureteroscopy
Participants will undergo flexible ureteroscopy assisted by a distal flexible suction ureteral access sheath for the treatment of 2-3 cm renal stones, according to the study protocol and device instructions for use.
Device: Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy
Flexible ureteroscopy for the treatment of 2-3 cm renal stones using a smart pressure-control system to regulate intrarenal pressure during lithotripsy. The procedure will be performed according to the study protocol and the device instructions for use.
Flexible ureteroscopy for the treatment of 2-3 cm renal stones using a distal flexible suction ureteral access sheath to facilitate stone fragment evacuation and urinary drainage during lithotripsy. The procedure will be performed according to the study protocol and the device instructions for use.
Immediate Stone-Free Rate
The proportion of patients with no residual renal stone fragments or only clinically insignificant residual fragments, as defined in the study protocol, confirmed by postoperative imaging immediately after surgery. The immediate stone-free rate will be compared between the smart pressure-controlled flexible ureteroscopy group and the distal flexible suction ureteral access sheath-assisted flexible ureteroscopy group.
Time frame: Within 24 hours after surgery
Postoperative Complication Rate
The proportion of patients experiencing intraoperative or postoperative complications associated with the surgical procedure, including infectious complications, ureteral injury, bleeding, and other adverse events. Complications will be assessed and graded according to the Clavien-Dindo classification.
Time frame: From surgery to 30 days after surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for Jan 2027, 2 months later.
Of 183 non-industry interventional studies with no phase under Kidney Calculi, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 54. This study's planned 2 months is below that.
Counting every sponsor, half of 199 studies reached it within 26 months; a quarter within 12 and three quarters within 51.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Guangzhou Medical University →