Pediatric UrolithiasisNCT07299032
Optical Motion Capture-Assisted Ultrasound for Pediatric ESWL
A study testing ESWL with Optical Motion Capture-Assisted Ultrasound Localization and ESWL with Conventional Ultrasound Localization in people with Pediatric Urolithiasis and Extracorporeal Shock Wave Lithotripsy, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
The incidence of pediatric urinary system stones has shown an upward trend in recent years, and Extracorporeal Shock Wave Lithotripsy (ESWL) has become one of the most important minimally invasive treatments for pediatric upper urinary tract stones. Read more about this study
- Who is it for?
- Ages 1 year to 14 years
- Conditions the study is for
- Pediatric Urolithiasis, Extracorporeal Shock Wave Lithotripsy, Optical Motion Capture
- What is being tested?
- ESWL with Optical Motion Capture-Assisted Ultrasound Localization and ESWL with Conventional Ultrasound Localization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Jan 2028
- 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 1 year to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients aged 0 to 14 years with a confirmed diagnosis of upper urinary tract stones.
- Diagnosis confirmed by ultrasound or low-dose CT; stone long diameter ≤ 20 mm (for upper ureteral stones, diameter ≤ 15 mm); absence of urinary tract structural malformations.
- Meeting the indications for ESWL with no absolute contraindications, and scheduled to undergo ESWL treatment.
- Guardians provide informed consent and voluntarily sign the written informed consent form; willing and able to cooperate with the 4-week postoperative follow-up and related examinations.
- Preoperative assessment reveals no contraindications to ESWL, such as uncontrolled infection, severe coagulation disorders, or severe impairment of cardiopulmonary, hepatic, or renal function.
Who cannot join
- Presence of absolute contraindications for ESWL: Uncontrolled severe urinary tract infection or sepsis; severe uncorrected coagulopathy or current use of anticoagulant/antiplatelet medications; severe renal impairment (significantly decreased GFR); active severe cardiopulmonary disease rendering the patient unable to tolerate anesthesia or shock wave therapy; or absence of an anatomically safe shock wave path (e.g., due to severe skeletal deformities).
- Stones suspected to be extremely hard or complex: Refractory stones indicated by excessively high CT Hounsfield Units (HU) or ultrasound Shear Wave Elastography (SWE) values > 13.7 kPa; or cystine stones in children > 2 years of age (associated with significantly low ESWL success rates).
- Anatomical or physiological challenges: Severe obesity that compromises ultrasound localization; or patients with a solitary kidney or poor contralateral renal function accompanied by a large stone burden.
- Prior intervention: History of prior ESWL or other lithotripsy procedures at the target site, which may confound the evaluation of therapeutic efficacy.
- Underlying systemic conditions: Comorbid severe metabolic diseases or hereditary stone diseases (e.g., cystinuria) requiring priority comprehensive management.
- Compliance issues: Guardians unable to cooperate with the complete follow-up process, or patients with a high anticipated risk of being lost to follow-up.
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
Children's hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
About this study
Official title: A Randomized Controlled Study on the Localization Efficiency of Optical Motion Capture-Assisted Ultrasound Pre-localization in Pediatric Extracorporeal Shock Wave Lithotripsy
The incidence of pediatric urinary system stones has shown an upward trend in recent years, and Extracorporeal Shock Wave Lithotripsy (ESWL) has become one of the most important minimally invasive treatments for pediatric upper urinary tract stones. Currently, the widely used clinical ultrasound mechanical coupling localization mode suffers from issues such as limited scanning degrees of freedom and difficulty in intuitively grasping the spatial relationship between the stone and the focal point. These issues lead to prolonged stone pre-localization times, significant reliance on operator experience, and a steep learning curve for young and primary care physicians, thereby restricting the standardization and widespread promotion of pediatric ESWL.
Building upon existing ESWL equipment, this project independently constructs an "Optical Motion Capture-Assisted Ultrasound Pre-localization System." By utilizing multi-camera infrared motion capture to acquire the 3D pose of the ultrasound probe and the shock wave source in real-time and establishing a unified spatial coordinate system, the system achieves automatic conversion and visual display of the stone's position from the ultrasound image to the shock wave focal point coordinates. This guides the operator to quickly complete focal point pre-localization after freely scanning for the stone. Results from preliminary phantom studies and initial clinical pilot experiments indicate that, while maintaining the routine ESWL workflow, this system can significantly shorten the first effective pre-localization time for pediatric stones from approximately 15 minutes to around 5 minutes, without a significant decrease in the stone clearance rate. This suggests the technology possesses good engineering feasibility and clinical application prospects.
Read more
This study proposes to conduct a single-center, prospective, single-blind randomized controlled clinical trial. Pediatric patients with upper urinary tract stones eligible for ESWL will be randomly assigned 1:1 to an experimental group and a control group. The experimental group will use the Optical Motion Capture-Assisted Ultrasound Pre-localization System for stone pre-localization, while the control group will use the routine ultrasound mechanical coupling localization method.
The primary outcome measure is the time to first effective stone pre-localization. Secondary outcomes include the stone clearance rate evaluated by imaging at 4 and 12 weeks post-operation, the total number of shock waves released and total energy, total procedure time, intraoperative and postoperative complication rates, sedation/anesthesia dosage, and family satisfaction. Additionally, the study will systematically evaluate the system's impact on physician learning curves and work intensity by analyzing the localization success rate of operators with different seniority levels, learning curves (the trend of localization time versus the number of cases), and subjective workload scores.
The core scientific question this project aims to answer is: Under the premise of not compromising the therapeutic efficacy and safety of pediatric ESWL, can optical motion capture-assisted ultrasound pre-localization significantly improve stone localization efficiency, reduce operator workload, and shorten the learning curve for young physicians, thereby enhancing the standardization and accessibility of pediatric ESWL? The expected results will provide an evidence-based foundation for optimizing pediatric ESWL localization modes and formulating relevant technical standards and training programs. Furthermore, it will lay the clinical validation groundwork for future intelligent lithotripsy systems integrating functions such as intelligent identification and robotic arm automatic tracking.
- Conditions
- Pediatric Urolithiasis, Extracorporeal Shock Wave Lithotripsy, Optical Motion Capture, Ultrasound Localization, Randomized Controlled Trial, Localization Efficiency
- Being tested
- ESWL with Optical Motion Capture-Assisted Ultrasound Localization, ESWL with Conventional Ultrasound Localization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ESWL with Optical Motion Capture-Assisted Ultrasound LocalizationDevice
Step 1: The physician holds the ultrasound probe to freely scan the patient's target area. Ultrasound images are displayed in real-time to identify and lock onto the stone's position.
Step 2: Activate the optical motion capture system. High-speed cameras capture the spatial trajectory of the ultrasound probe, while synchronized AI algorithms recognize the stone image to digitally generate the stone's 3D spatial coordinates.
Step 3: The system automatically matches the position of the ultrasound probe with the shock wave source. Using preset algorithms, it drives the robotic arm to fine-tune the posture, completing the focal point alignment between the probe and the wave source. This ensures the stone is precisely located at the central focus of the lithotripsy energy. Once localization is complete, relevant equipment parameters are locked.
ESWL with Conventional Ultrasound LocalizationDevice
- The physician performs a freehand ultrasound scan based on clinical experience to locate the stone and verify its position.
- The ultrasound probe is secured to the dedicated ultrasound bracket of the Dornier lithotripter. The physician manually adjusts the bracket angle while simultaneously controlling the lithotripter's X, Y, and Z-axis movements. The ultrasound image is repeatedly aligned until the stone is confirmed to be precisely located at the focal point of the shock wave energy. Upon completion of localization, the equipment parameters are locked.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | ESWL with Optical Motion Capture-Assisted Ultrasound Localization Receives: Device: ESWL with Optical Motion Capture-Assisted Ultrasound Localization |
| Control Group | Active comparator | ESWL with Conventional Ultrasound Localization Receives: Device: ESWL with Conventional Ultrasound Localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Duration of Ultrasound Localization Operation
Defined as the total duration from the initiation of ultrasound localization until the complete conclusion of the target therapeutic procedure (core lithotripsy-related operations) and the withdrawal of instruments. This excludes time for preoperative preparation, anesthesia, and basic postoperative care. It is recorded in real-time using a precise timing tool.
Measured: Timed for the entire duration of a single procedure; calculated immediately upon the conclusion of the operation.
Secondary outcomes (2)
Stone Clearance Rate at 4 Weeks Post-operation
Defined as the proportion of pediatric patients in each group who achieve clinical success in ESWL for the target stone relative to the total number of study cases in that group at 4 weeks post-operation. The determination is primarily based on ultrasound examination results, combined with a comprehensive assessment of the patient's clinical symptoms.
Measured: Week 4 after completion of ESWL.
Localization Accuracy of Optical Motion Capture Assistance
Calculated by assessing the accuracy on the x, y, and z axes for both the optical motion capture-assisted ultrasound localization and the conventional Dornier lithotripter ultrasound localization. Specifically, it measures the deviation between the localization result and the actual stone position (a deviation of ≤5mm on each axis is defined as "accurate"). The metric is the proportion of cases deemed accurate out of the total number of cases for the respective localization method. Immediately after ultrasound localization, the deviation is verified using the optical capture coordinate system to assess the degree of matching.
Measured: Measured and verified immediately upon completion of the localization for a single procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric UrolithiasisStudies of the same condition, open and under way.
- More trials run by The Children's Hospital of 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qibo Hu, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299032
- Sponsor's protocol ID
- URO-2025-12
- Status last verified
- Jan 2026
- First submitted
- 10 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on the Localization Efficiency of Optical Motion Capture-Assisted Ultrasound Pre-localization in Pediatric Extracorporeal Shock Wave Lithotripsy
- ClinicalTrials.gov ID
- NCT07299032
- Acronym / sponsor ID
- URO-2025-12
- Conditions
- Pediatric Urolithiasis, Extracorporeal Shock Wave Lithotripsy, Optical Motion Capture, Ultrasound Localization, Randomized Controlled Trial, Localization Efficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 23 Dec 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 incidence of pediatric urinary system stones has shown an upward trend in recent years, and Extracorporeal Shock Wave Lithotripsy (ESWL) has become one of the most important minimally invasive treatments for pediatric upper urinary tract stones. Currently, the widely used clinical ultrasound mechanical coupling localization mode suffers from issues such as limited scanning degrees of freedom and difficulty in intuitively grasping the spatial relationship between the stone and the focal point. These issues lead to prolonged stone pre-localization times, significant reliance on operator experience, and a steep learning curve for young and primary care physicians, thereby restricting the standardization and widespread promotion of pediatric ESWL.
Building upon existing ESWL equipment, this project independently constructs an "Optical Motion Capture-Assisted Ultrasound Pre-localization System." By utilizing multi-camera infrared motion capture to acquire the 3D pose of the ultrasound probe and the shock wave source in real-time and establishing a unified spatial coordinate system, the system achieves automatic conversion and visual display of the stone's position from the ultrasound image to the shock wave focal point coordinates. This guides the operator to quickly complete focal point pre-localization after freely scanning for the stone. Results from preliminary phantom studies and initial clinical pilot experiments indicate that, while maintaining the routine ESWL workflow, this system can significantly shorten the first effective pre-localization time for pediatric stones from approximately 15 minutes to around 5 minutes, without a significant decrease in the stone clearance rate. This suggests the technology possesses good engineering feasibility and clinical application prospects.
This study proposes to conduct a single-center, prospective, single-blind randomized controlled clinical trial. Pediatric patients with upper urinary tract stones eligible for ESWL will be randomly assigned 1:1 to an experimental group and a control group. The experimental group will use the Optical Motion Capture-Assisted Ultrasound Pre-localization System for stone pre-localization, while the control group will use the routine ultrasound mechanical coupling localization method.
The primary outcome measure is the time to first effective stone pre-localization. Secondary outcomes include the stone clearance rate evaluated by imaging at 4 and 12 weeks post-operation, the total number of shock waves released and total energy, total procedure time, intraoperative and postoperative complication rates, sedation/anesthesia dosage, and family satisfaction. Additionally, the study will systematically evaluate the system's impact on physician learning curves and work intensity by analyzing the localization success rate of operators with different seniority levels, learning curves (the trend of localization time versus the number of cases), and subjective workload scores.
The core scientific question this project aims to answer is: Under the premise of not compromising the therapeutic efficacy and safety of pediatric ESWL, can optical motion capture-assisted ultrasound pre-localization significantly improve stone localization efficiency, reduce operator workload, and shorten the learning curve for young physicians, thereby enhancing the standardization and accessibility of pediatric ESWL? The expected results will provide an evidence-based foundation for optimizing pediatric ESWL localization modes and formulating relevant technical standards and training programs. Furthermore, it will lay the clinical validation groundwork for future intelligent lithotripsy systems integrating functions such as intelligent identification and robotic arm automatic tracking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: ESWL with Optical Motion Capture-Assisted Ultrasound LocalizationESWL with Optical Motion Capture-Assisted Ultrasound Localization |
| Control Group | Active comparator | Device: ESWL with Conventional Ultrasound LocalizationESWL with Conventional Ultrasound Localization |
Who may qualify
- Ages
- 1 year to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Pediatric patients aged 0 to 14 years with a confirmed diagnosis of upper urinary tract stones.
- Diagnosis confirmed by ultrasound or low-dose CT; stone long diameter ≤ 20 mm (for upper ureteral stones, diameter ≤ 15 mm); absence of urinary tract structural malformations.
- Meeting the indications for ESWL with no absolute contraindications, and scheduled to undergo ESWL treatment.
- Guardians provide informed consent and voluntarily sign the written informed consent form; willing and able to cooperate with the 4-week postoperative follow-up and related examinations.
- Preoperative assessment reveals no contraindications to ESWL, such as uncontrolled infection, severe coagulation disorders, or severe impairment of cardiopulmonary, hepatic, or renal function.
Key exclusion criteria (6 listed)
- Presence of absolute contraindications for ESWL: Uncontrolled severe urinary tract infection or sepsis; severe uncorrected coagulopathy or current use of anticoagulant/antiplatelet medications; severe renal impairment (significantly decreased GFR); active severe cardiopulmonary disease rendering the patient unable to tolerate anesthesia or shock wave therapy; or absence of an anatomically safe shock wave path (e.g., due to severe skeletal deformities).
- Stones suspected to be extremely hard or complex: Refractory stones indicated by excessively high CT Hounsfield Units (HU) or ultrasound Shear Wave Elastography (SWE) values > 13.7 kPa; or cystine stones in children > 2 years of age (associated with significantly low ESWL success rates).
- Anatomical or physiological challenges: Severe obesity that compromises ultrasound localization; or patients with a solitary kidney or poor contralateral renal function accompanied by a large stone burden.
- Prior intervention: History of prior ESWL or other lithotripsy procedures at the target site, which may confound the evaluation of therapeutic efficacy.
- Underlying systemic conditions: Comorbid severe metabolic diseases or hereditary stone diseases (e.g., cystinuria) requiring priority comprehensive management.
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 |
|---|---|---|
| ESWL with Optical Motion Capture-Assisted Ultrasound LocalizationStep 1: The physician holds the ultrasound probe to freely scan the patient's target area. Ultrasound images are displayed in real-time to identify and lock onto the stone's position. Step 2: Activate the optical motion capture system. High-speed cameras capture the spatial trajectory of the ultrasound probe, while synchronized AI algorithms recognize the stone image to digitally generate the stone's 3D spatial coordinates. Step 3: The system automatically matches the position of the ultrasound probe with the shock wave source. Using preset algorithms, it drives the robotic arm to fine-tune the posture, completing the focal point alignment between the probe and the wave source. This ensures the stone is precisely located at the central focus of the lithotripsy energy. Once localization is complete, relevant equipment parameters are locked. | Device | Experimental Group |
| ESWL with Conventional Ultrasound Localization1. The physician performs a freehand ultrasound scan based on clinical experience to locate the stone and verify its position. 2. The ultrasound probe is secured to the dedicated ultrasound bracket of the Dornier lithotripter. The physician manually adjusts the bracket angle while simultaneously controlling the lithotripter's X, Y, and Z-axis movements. The ultrasound image is repeatedly aligned until the stone is confirmed to be precisely located at the focal point of the shock wave energy. Upon completion of localization, the equipment parameters are locked. | Device | Control Group |
Primary outcome
Total Duration of Ultrasound Localization Operation
Time frame: Timed for the entire duration of a single procedure; calculated immediately upon the conclusion of the operation.
Defined as the total duration from the initiation of ultrasound localization until the complete conclusion of the target therapeutic procedure (core lithotripsy-related operations) and the withdrawal of instruments. This excludes time for preoperative preparation, anesthesia, and basic postoperative care. It is recorded in real-time using a precise timing tool.
2 secondary outcomes
Stone Clearance Rate at 4 Weeks Post-operation
Time frame: Week 4 after completion of ESWL.
Localization Accuracy of Optical Motion Capture Assistance
Time frame: Measured and verified immediately upon completion of the localization for a single procedure.
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 6 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ESWL with Optical Motion Capture-Assisted Ultrasound Localization and ESWL with Conventional Ultrasound Localization in people with Pediatric Urolithiasis and Extracorporeal Shock Wave Lithotripsy, run by The Children's Hospital of 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 5 inclusion and 6 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 6 Jan 2026. 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 Qibo Hu, MD (+86 19857138381, huqibo_578@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Duration of Ultrasound Localization Operation (time frame: Timed for the entire duration of a single procedure; calculated immediately upon the conclusion of the operation.). 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 6 Jan 2026.