Camera-Assisted ultrasound could cut kidney stone procedure time by Two-Thirds in kids
NCT ID NCT07299032
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether a new system using cameras to track an ultrasound probe can help doctors find kidney stones faster in children undergoing shock wave lithotripsy. Eighty children with upper urinary tract stones will be randomly assigned to either the new camera-assisted method or the standard ultrasound method. The main goal is to see if the new system reduces the time needed to locate the stone before treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Optical motion capture-assisted ultrasound localization system (device)
- What this could lead to
- If successful, this technology could make pediatric kidney stone treatment faster and easier for doctors, potentially reducing procedure time from 15 to 5 minutes.
- What could go wrong
- This is a small, early-stage trial (80 children) testing a device, not a drug. It may not work in all cases or may not improve stone clearance rates. The technology is new and needs more testing.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 14 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Children's hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052, China
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