Urolithiasis, Calcium OxalateNCT07071948
A Single-Center Clinical Study on the Efficacy and Safety of VISOR
A study testing Multifunctional Integrated Flexible Ureteroscope in people with Urolithiasis, Calcium Oxalate and Kidney Stone, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Goal of this trial: To test a new tool called VISOR in adults (aged 18-80) with 1-3 cm kidney or ureter stones. We want to see: 1. If it's safe and works well 2. If its built-in features (flushing/suction, pressure control, and stone-breaking/removal) help clear stones better while keeping surgery safe. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Urolithiasis, Calcium Oxalate, Kidney Stone
- What is being tested?
- Multifunctional Integrated Flexible Ureteroscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2025to 28 Feb 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 1-3 cm
- Patients who choose to undergo "flexible ureteroscopic holmium laser lithotripsy"
- Aged 18-80 years, regardless of gender
- Subjects without mental illness or language dysfunction, who can understand the details of this study and sign the informed consent form
Who cannot join
- Patients with ureteral stricture or a history of ureteral stricture
- Patients with a history of open renal and/or ureteral surgery or laparoscopic surgery
- Fever (body temperature ≥ 38℃) due to urinary tract infection or other reasons within one week before surgery
- Pregnant women, lactating women, or women who are in the menstrual period
- ASA classification > Grade 3: patients with severe systemic diseases, heart diseases, pulmonary insufficiency, and failure of important organ functions, etc., who cannot tolerate anesthesia or surgery
- Patients with anatomical malformations such as polycystic kidney, horseshoe kidney, and ectopic kidney
- Patients with abnormal coagulation function (e.g., international normalized ratio (INR) > 1.5 or platelet count < 80 × 10⁹/L)
- Patients with failed sheath placement during surgery
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, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 230000
Bohan Wang, MD., Ph.D, +86-13575799866, wangbohan@zju.edu.cn
Wenjun Gao, MD., Ph.D, 086-19817482099, gaowenjun@zju.edu.cn
About this study
Official title: A Single-Center Clinical Study on the Efficacy and Safety of Vortex Intelligence Stone Optimized Removal (VISOR)
Goal of this trial:
To test a new tool called VISOR in adults (aged 18-80) with 1-3 cm kidney or ureter stones. We want to see:
Read more
- If it's safe and works well
- If its built-in features (flushing/suction, pressure control, and stone-breaking/removal) help clear stones better while keeping surgery safe.
Main questions:
- Can the VISOR clear stones successfully (with fragments <4 mm left) for at least 9 out of every 10 people within 24 hours after surgery?
- Will serious problems (like severe infections or ureteral injuries) happen to no more than 1 in 20 people (5%)?
- Can the device keep pressure inside the kidney below 30 mmHg (a safe level) during the entire surgery?
What participants will do:
Have stone removal surgery using VISOR (breaks and removes stones at the same time).
Get a CT scan within 24 hours after surgery to check if stones are cleared.
Return 4 weeks (±1 week) after surgery for:
An imaging test (CT or ultrasound)
A check for any health problems related to the surgery.
- Conditions
- Urolithiasis, Calcium Oxalate, Kidney Stone
- Being tested
- Multifunctional Integrated Flexible Ureteroscope
- Keywords
- urolithiasis, kidney stone, stone free rate, VISOR
- Medical subject headings
- Nephrolithiasis, Calcium Oxalate, Kidney Calculi, Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multifunctional Integrated Flexible UreteroscopeDevice
Also called Xinwell Scope
Investigational ureteroscope with three integrated functions:
- Real-time pressure control: Continuous renal pelvic pressure monitoring with auto-adjustment of irrigation/aspiration flow to maintain pressure <30 mmHg (safety threshold)
- Simultaneous lithotripsy \& fragment removal: Holmium laser lithotripsy (200-365 μm fiber) coordinated with suction through working channel
- Single-pass stone clearance: Designed to reduce residual fragments requiring secondary procedures
Distinguishing features vs conventional ureteroscopes:
- Eliminates need for separate suction devices
- Prevents intraoperative "washout failure" causing obscured vision
- Patent-pending pressure sensor
| Study group | Role | What they receive |
|---|---|---|
| VISOR Treatment | Experimental | All enrolled participants (n=20) will undergo upper urinary tract stone removal using the investigational device VISOR (Vortex Intelligence Stone Optimized Removal). The procedure includes:
1. Integrated irrigation-aspiration and real-time pressure monitoring/control (safety threshold: <30 mmHg).
2. Holmium laser lithotripsy with simultaneous stone fragment removal.
3. Postoperative assessment:
Urinary CT scan at 24h to determine immediate stone-free rate (residual stones <4 mm).
Follow-up imaging (CT/ultrasound) and complication monitoring at 28±7 days. Receives: Device: Multifunctional Integrated Flexible Ureteroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour stone-free rate after Xinwell Scope lithotripsy
Proportion of participants with complete stone clearance (defined as no residual fragment ≥4 mm in maximum diameter) assessed by non-contrast urinary CT scan within 24 hours post-surgery. Calculated as:
(Number of patients with residual stones <4 mm / Total analyzed participants) × 100% Significance: Directly evaluates the device's integrated suction function for real-time fragment removal during the procedure.
Measured: within 24 hours postoperatively
Secondary outcomes (5)
1-month stone-free rate
Proportion of participants with residual stones <4 mm assessed by CT (if baseline residual ≥4 mm) or renal ultrasound (if no baseline residual) at 28±7 days post-surgery.
Measured: 28±7 days postoperatively
Operative time
Duration (minutes) from initial ureteroscope insertion to final removal.
Measured: During surgery
Intraoperative renal pelvic pressure
Mean/Max pressure (mmHg) recorded by built-in sensor. Safety target: <30 mmHg.
Measured: Continuous monitoring during lithotripsy
Ureteral injury rate
Graded via intraoperative video review:
Grade 0: Mucosal bleeding only
Grade 1-4: Mucosal to full-thickness injury
Measured: During surgery
Postoperative complication rate
Includes:
Fever (>38.0°C within 24h)
Clavien-Dindo grade ≥II complications
Ureteral stenosis (imaging-confirmed at 1 months)
Measured: 24h, 28 ±7 days , 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start6 Aug 2025
- Primary completion31 Oct 2025 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urolithiasis, Calcium OxalateStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- NCT07071948
- Sponsor's protocol ID
- 2025-0324
- Status last verified
- Jul 2025
- First submitted
- 14 Jul 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 1. Intellectual Property Protection * The investigational device (Xinwell Scope) contains patent-pending technologies owned by Ningbo Xinwell Medical Technology Co., Ltd. * Public disclosure of raw performance data (e.g., real-time pelvic pressure metrics) may compromise proprietary algorithms. 2. Privacy Risks of De-identified Data * Key datasets (intraoperative videos, dynamic pressure recordings) carry re-identification risks despite de-identification.
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Clinical Study on the Efficacy and Safety of Vortex Intelligence Stone Optimized Removal (VISOR)
- ClinicalTrials.gov ID
- NCT07071948
- Acronym / sponsor ID
- 2025-0324
- Conditions
- Urolithiasis, Calcium Oxalate, Kidney Stone
- Keywords
- urolithiasis, kidney stone, stone free rate, VISOR
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 6 Aug 2025 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 18 Jul 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.
Goal of this trial:
To test a new tool called VISOR in adults (aged 18-80) with 1-3 cm kidney or ureter stones. We want to see:
- If it's safe and works well
- If its built-in features (flushing/suction, pressure control, and stone-breaking/removal) help clear stones better while keeping surgery safe.
Main questions:
- Can the VISOR clear stones successfully (with fragments <4 mm left) for at least 9 out of every 10 people within 24 hours after surgery?
- Will serious problems (like severe infections or ureteral injuries) happen to no more than 1 in 20 people (5%)?
- Can the device keep pressure inside the kidney below 30 mmHg (a safe level) during the entire surgery?
What participants will do:
Have stone removal surgery using VISOR (breaks and removes stones at the same time).
Get a CT scan within 24 hours after surgery to check if stones are cleared.
Return 4 weeks (±1 week) after surgery for:
An imaging test (CT or ultrasound)
A check for any health problems related to the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VISOR Treatment | Experimental | Device: Multifunctional Integrated Flexible UreteroscopeAll enrolled participants (n=20) will undergo upper urinary tract stone removal using the investigational device VISOR (Vortex Intelligence Stone Optimized Removal). The procedure includes: 1. Integrated irrigation-aspiration and real-time pressure monitoring/control (safety threshold: <30 mmHg). 2. Holmium laser lithotripsy with simultaneous stone fragment removal. 3. Postoperative assessment: Urinary CT scan at 24h to determine immediate stone-free rate (residual stones <4 mm). Follow-up imaging (CT/ultrasound) and complication monitoring at 28±7 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with upper urinary tract calculi, where the maximum diameter of a single calculus or the cumulative diameter of multiple calculi is 1-3 cm
- Patients who choose to undergo "flexible ureteroscopic holmium laser lithotripsy"
- Aged 18-80 years, regardless of gender
- Subjects without mental illness or language dysfunction, who can understand the details of this study and sign the informed consent form
Key exclusion criteria (8 listed)
- Patients with ureteral stricture or a history of ureteral stricture
- Patients with a history of open renal and/or ureteral surgery or laparoscopic surgery
- Fever (body temperature ≥ 38℃) due to urinary tract infection or other reasons within one week before surgery
- Pregnant women, lactating women, or women who are in the menstrual period
- ASA classification > Grade 3: patients with severe systemic diseases, heart diseases, pulmonary insufficiency, and failure of important organ functions, etc., who cannot tolerate 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 |
|---|---|---|
| Multifunctional Integrated Flexible UreteroscopeAlso: Xinwell ScopeInvestigational ureteroscope with three integrated functions: 1. Real-time pressure control: Continuous renal pelvic pressure monitoring with auto-adjustment of irrigation/aspiration flow to maintain pressure <30 mmHg (safety threshold) 2. Simultaneous lithotripsy \& fragment removal: Holmium laser lithotripsy (200-365 μm fiber) coordinated with suction through working channel 3. Single-pass stone clearance: Designed to reduce residual fragments requiring secondary procedures Distinguishing features vs conventional ureteroscopes: 1. Eliminates need for separate suction devices 2. Prevents intraoperative "washout failure" causing obscured vision 3. Patent-pending pressure sensor | Device | VISOR Treatment |
Primary outcome
24-hour stone-free rate after Xinwell Scope lithotripsy
Time frame: within 24 hours postoperatively
Proportion of participants with complete stone clearance (defined as no residual fragment ≥4 mm in maximum diameter) assessed by non-contrast urinary CT scan within 24 hours post-surgery. Calculated as: (Number of patients with residual stones <4 mm / Total analyzed participants) × 100% Significance: Directly evaluates the device's integrated suction function for real-time fragment removal during the procedure.
5 secondary outcomes
1-month stone-free rate
Time frame: 28±7 days postoperatively
Operative time
Time frame: During surgery
Intraoperative renal pelvic pressure
Time frame: Continuous monitoring during lithotripsy
Ureteral injury rate
Time frame: During surgery
Postoperative complication rate
Time frame: 24h, 28 ±7 days , 1 month
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 26 Sep 2025.
- Individual participant dataSharing planned: No. 1. Intellectual Property Protection * The investigational device (Xinwell Scope) contains patent-pending technologies owned by Ningbo Xinwell Medical Technology Co., Ltd. * Public disclosure of raw performance data (e.g., real-time pelvic pressure metrics) may compromise proprietary algorithms. 2. Privacy Risks of De-identified Data * Key datasets (intraoperative videos, dynamic pressure recordings) carry re-identification risks despite de-identification.
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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 Multifunctional Integrated Flexible Ureteroscope in people with Urolithiasis, Calcium Oxalate and Kidney Stone, 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 4 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: looking for participants now, as of the sponsor's last update on 26 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?
Contact Bohan Wang, MD., Ph.D (+86-13575799866, wangbohan@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour stone-free rate after Xinwell Scope lithotripsy (time frame: within 24 hours postoperatively). 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 26 Sep 2025.