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Camera-Assisted ultrasound could cut kidney stone procedure time by Two-Thirds in kids

NCT ID NCT07299032

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
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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

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

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

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

1 year to 14 years

Sex

Anyone

Healthy volunteers

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

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

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Children's hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052, China

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