Kidney CalculiNCT07159503
VISOR Versus PCNL for Treatment of 2-4cm Renal Stones
A study testing Vortex Intelligence Stone Optimized Removal and Percutaneous Nephrolithotomy (PCNL) in people with Kidney Calculi and Kidney Stones, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if the Vortex Intelligence Stone Optimized Removal (VISOR) works safely and effectively to treat kidney stones that are 2 to 4 centimeters in size in kidney. This study will also look at how VISOR compares to the standard surgery, percutaneous nephrolithotomy (PCNL). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Kidney Calculi, Kidney Stones
- What is being tested?
- Vortex Intelligence Stone Optimized Removal and Percutaneous Nephrolithotomy (PCNL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2025to 20 Aug 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
- Patients with upper urinary tract calculi, where the maximum diameter of a single calculus or the cumulative diameter of multiple calculi is 2-4 cm
- Age between 18 and 80 years, regardless of gender
- Mentally sound and able to comprehend study details and provide informed consent
Who cannot join
- Presence of ureteral stricture or history thereof
- Previous open or laparoscopic renal and/or ureteral surgery
- Fever (body temperature ≥ 38℃) due to urinary tract infection or other causes within one week prior to surgery
- Pregnancy, lactation, or menstruation at the time of surgery
- ASA classification > Grade 3, indicating severe systemic disease that contraindicates anesthesia or surgery
- Renal anatomical anomalies such as polycystic kidney, horseshoe kidney, or ectopic kidney
- Coagulation dysfunction (e.g., INR > 1.5 or platelet count < 80 × 10⁹/L)
- Intraoperative failure to successfully place the ureteral access sheath
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 230000
About this study
Official title: Vortex Intelligence Stone Optimized Removal Versus Percutaneous Nephrolithotomy for Treatment of 2-4cm Renal Stones
The goal of this clinical trial is to learn if the Vortex Intelligence Stone Optimized Removal (VISOR) works safely and effectively to treat kidney stones that are 2 to 4 centimeters in size in kidney. This study will also look at how VISOR compares to the standard surgery, percutaneous nephrolithotomy (PCNL).
The main questions it aims to answer are:
Read more
How many participants are stone-free within 24 hours after surgery?
How many participants are stone-free 1 month after surgery?
What side effects or problems, such as pain, fever, or ureter injury, happen with VISOR compared to PCNL?
Does VISOR help keep kidney pressure stable during surgery?
Researchers will compare VISOR to PCNL to see which treatment works better and is safer.
Participants will:
Be randomly assigned to have surgery with either VISOR or PCNL.
Have imaging tests, such as CT scans or ultrasound, after surgery to check if stones were cleared.
Return for follow-up visits about 2 weeks and 1 month after surgery to check recovery and repeat imaging.
About 170 people will take part in this study at cooperative hospitals.
- Conditions
- Kidney Calculi, Kidney Stones
- Being tested
- Vortex Intelligence Stone Optimized Removal, Percutaneous Nephrolithotomy (PCNL)
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vortex Intelligence Stone Optimized RemovalProcedure or surgery
Vortex Intelligence Stone Optimized Removal integrates irrigation-suction, pressure monitoring-control, and lithotripsy-stone removal functions, aiming to improve stone clearance efficiency, stabilize intrapelvic pressure, and reduce complications.
Percutaneous Nephrolithotomy (PCNL)Procedure or surgery
A standard PCNL technique will be performed according to institutional practice guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: VISOR | Experimental | Participants will undergo Vortex Intelligence Stone Optimized Removal. Receives: Procedure: Vortex Intelligence Stone Optimized Removal |
| PCNL Group | Active comparator | Participants undergo standard percutaneous nephrolithotomy (PCNL) for renal stone removal. Receives: Procedure: Percutaneous Nephrolithotomy (PCNL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone-free rate within 24 hours
The percentage of participants whose kidney stones are completely cleared within 24 hours after surgery, as confirmed by CT scan.
Measured: 24 hours after surgery
Secondary outcomes (5)
Stone-free rate at 1 month
The percentage of participants whose stones are completely cleared at 1 month after surgery, evaluated using CT or ultrasound.
Measured: 28 ± 7 days after surgery
Operative Time
Total time from the beginning to the end of the surgery, measured in minutes.
Measured: During surgery (Day 0)
Postoperative fever
Incidence of participants experiencing a body temperature ≥38°C within 30 days after surgery.
Measured: 0-30 days after surgery
Postoperative ureteral stricture
Occurrence of ureteral narrowing detected by imaging within 1 month after surgery.
Measured: 28 ± 7 days after surgery
Pain assessment (VAS score)
Participants report their pain using the Visual Analog Scale (VAS) at different time points postoperatively.
Measured: Postoperative Day 0-28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start20 Apr 2025
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bohan Wang, MD., Ph.D, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07159503
- Sponsor's protocol ID
- 2025-134
- Status last verified
- Aug 2025
- First submitted
- 29 Aug 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vortex Intelligence Stone Optimized Removal Versus Percutaneous Nephrolithotomy for Treatment of 2-4cm Renal Stones
- ClinicalTrials.gov ID
- NCT07159503
- Acronym / sponsor ID
- 2025-134
- Conditions
- Kidney Calculi, Kidney Stones
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 20 Apr 2025 (actual)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 8 Sep 2025 (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.
The goal of this clinical trial is to learn if the Vortex Intelligence Stone Optimized Removal (VISOR) works safely and effectively to treat kidney stones that are 2 to 4 centimeters in size in kidney. This study will also look at how VISOR compares to the standard surgery, percutaneous nephrolithotomy (PCNL).
The main questions it aims to answer are:
How many participants are stone-free within 24 hours after surgery?
How many participants are stone-free 1 month after surgery?
What side effects or problems, such as pain, fever, or ureter injury, happen with VISOR compared to PCNL?
Does VISOR help keep kidney pressure stable during surgery?
Researchers will compare VISOR to PCNL to see which treatment works better and is safer.
Participants will:
Be randomly assigned to have surgery with either VISOR or PCNL.
Have imaging tests, such as CT scans or ultrasound, after surgery to check if stones were cleared.
Return for follow-up visits about 2 weeks and 1 month after surgery to check recovery and repeat imaging.
About 170 people will take part in this study at cooperative hospitals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: VISOR | Experimental | Procedure: Vortex Intelligence Stone Optimized RemovalParticipants will undergo Vortex Intelligence Stone Optimized Removal. |
| PCNL Group | Active comparator | Procedure: Percutaneous Nephrolithotomy (PCNL)Participants undergo standard percutaneous nephrolithotomy (PCNL) for renal stone removal. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with upper urinary tract calculi, where the maximum diameter of a single calculus or the cumulative diameter of multiple calculi is 2-4 cm
- Age between 18 and 80 years, regardless of gender
- Mentally sound and able to comprehend study details and provide informed consent
Key exclusion criteria (8 listed)
- Presence of ureteral stricture or history thereof
- Previous open or laparoscopic renal and/or ureteral surgery
- Fever (body temperature ≥ 38℃) due to urinary tract infection or other causes within one week prior to surgery
- Pregnancy, lactation, or menstruation at the time of surgery
- ASA classification > Grade 3, indicating severe systemic disease that contraindicates anesthesia or surgery
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 |
|---|---|---|
| Vortex Intelligence Stone Optimized RemovalVortex Intelligence Stone Optimized Removal integrates irrigation-suction, pressure monitoring-control, and lithotripsy-stone removal functions, aiming to improve stone clearance efficiency, stabilize intrapelvic pressure, and reduce complications. | Procedure or surgery | Experimental: VISOR |
| Percutaneous Nephrolithotomy (PCNL)A standard PCNL technique will be performed according to institutional practice guidelines. | Procedure or surgery | PCNL Group |
Primary outcome
Stone-free rate within 24 hours
Time frame: 24 hours after surgery
The percentage of participants whose kidney stones are completely cleared within 24 hours after surgery, as confirmed by CT scan.
5 secondary outcomes
Stone-free rate at 1 month
Time frame: 28 ± 7 days after surgery
Operative Time
Time frame: During surgery (Day 0)
Postoperative fever
Time frame: 0-30 days after surgery
Postoperative ureteral stricture
Time frame: 28 ± 7 days after surgery
Pain assessment (VAS score)
Time frame: Postoperative Day 0-28
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 12 Sep 2025.
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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.
Bohan Wang, MD., Ph.D principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vortex Intelligence Stone Optimized Removal and Percutaneous Nephrolithotomy (PCNL) in people with Kidney Calculi and Kidney Stones, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
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 3 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: enrolling by invitation, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stone-free rate within 24 hours (time frame: 24 hours after surgery). 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 12 Sep 2025.