Kidney StonesNCT07909577
Comparison of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy for 2-3 cm Renal Stones
A study testing Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy in people with Kidney Stones, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Stones
- What is being tested?
- Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years
- Patients diagnosed with renal stones measuring 2-3 cm based on preoperative imaging
- Unilateral renal stones suitable for flexible ureteroscopy
- Eligible for surgical treatment under general anesthesia
- Able and willing to provide written informed consent
Who cannot join
- Patients with active urinary tract infection that has not been adequately treated
- Patients with severe coagulation disorders or contraindications to surgery.
- Patients with severe cardiopulmonary dysfunction or other conditions that make surgery unsafe.
- Patients with anatomical abnormalities of the urinary tract that significantly affect the planned procedure.
- Patients with bilateral renal stones requiring simultaneous bilateral treatment.
- Pregnant or breastfeeding women.
- Patients participating in other clinical studies that may interfere with this study.
- Patients considered unsuitable for participation by the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Multicenter, Randomized, Non-Inferiority Controlled Trial Comparing the Efficacy and Safety of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Ureteroscopy Assisted by a Distal Flexible Suction Ureteral Access Sheath for the Treatment of 2-3 cm Renal Stones
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.
Read the detailed description
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.
- Conditions
- Kidney Stones
- Being tested
- Smart Pressure-Controlled Flexible Ureteroscopy, Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy
- Keywords
- Flexible ureteroscopy, kidney stones, Suction ureteral access sheath, Intrarenal pressure
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Pressure-Controlled Flexible UreteroscopyDevice
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.
Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible UreteroscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Smart Pressure-Controlled Flexible Ureteroscopy | Experimental | 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. Receives: Device: Smart Pressure-Controlled Flexible Ureteroscopy |
| Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy | Active comparator | 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. Receives: Device: Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From surgery to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney StonesStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel treatment arms: smart pressure-controlled flexible ureteroscopy or flexible ureteroscopy assisted by a distal flexible suction ureteral access sheath. The efficacy and safety of the two approaches will be compared.
- Masking
- None (open label)
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Junhao Zheng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909577
- Sponsor's protocol ID
- GYFYZJH20261019
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized, Non-Inferiority Controlled Trial Comparing the Efficacy and Safety of Smart Pressure-Controlled Flexible Ureteroscopy and Flexible Ureteroscopy Assisted by a Distal Flexible Suction Ureteral Access Sheath for the Treatment of 2-3 cm Renal Stones
- ClinicalTrials.gov ID
- NCT07909577
- Acronym / sponsor ID
- GYFYZJH20261019
- Conditions
- Kidney Stones
- Keywords
- Flexible ureteroscopy, kidney stones, Suction ureteral access sheath, Intrarenal pressure
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to two parallel treatment arms: smart pressure-controlled flexible ureteroscopy or flexible ureteroscopy assisted by a distal flexible suction ureteral access sheath. The efficacy and safety of the two approaches will be compared.
| Arm | Type | Receives |
|---|---|---|
| Smart Pressure-Controlled Flexible Ureteroscopy | Experimental | Device: Smart Pressure-Controlled Flexible UreteroscopyParticipants 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. |
| Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy | Active comparator | Device: Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible UreteroscopyParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-75 years
- Patients diagnosed with renal stones measuring 2-3 cm based on preoperative imaging
- Unilateral renal stones suitable for flexible ureteroscopy
- Eligible for surgical treatment under general anesthesia
- Able and willing to provide written informed consent
Key exclusion criteria (8 listed)
- Patients with active urinary tract infection that has not been adequately treated
- Patients with severe coagulation disorders or contraindications to surgery.
- Patients with severe cardiopulmonary dysfunction or other conditions that make surgery unsafe.
- Patients with anatomical abnormalities of the urinary tract that significantly affect the planned procedure.
- Patients with bilateral renal stones requiring simultaneous bilateral treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Pressure-Controlled Flexible UreteroscopyFlexible 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. | Device | Smart Pressure-Controlled Flexible Ureteroscopy |
| Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible UreteroscopyFlexible 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. | Device | Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy |
Primary outcome
Immediate Stone-Free Rate
Time frame: Within 24 hours after surgery
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.
Postoperative Complication Rate
Time frame: From surgery to 30 days after surgery
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Distal Flexible Suction Ureteral Access Sheath-Assisted Flexible Ureteroscopy in people with Kidney Stones, run by The First Affiliated Hospital of Guangzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact YongDa Liu, PhD (13719007083, 13719007083@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate Stone-Free Rate (time frame: Within 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.