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AI could help babies avoid unnecessary kidney surgery

NCT ID NCT07581223

Diagnosis Sponsor: The Hospital for Sick Children Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests an AI tool that analyzes ultrasound images to help doctors decide if a baby with hydronephrosis (kidney swelling) needs surgery. About 322 infants up to 24 months old will take part. Doctors first make a care plan without the AI, then see the AI's prediction and can change their plan. A separate expert makes the final decision to ensure safety. The goal is to see if the AI improves decision-making and reduces the need for invasive tests.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
AI-driven decision-making tool (machine learning model)
What this could lead to
If successful, this AI tool could help doctors make faster, more accurate decisions about whether a baby with kidney swelling needs surgery, reducing unnecessary invasive tests.
What could go wrong
This is an early-stage study testing how well the AI fits into real-world care. It may not improve decisions or could be difficult to integrate into busy clinics.

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 322 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jan 2027

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

0 to 24 months

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: * Seen for HN in-person in the Pediatric Urology clinic with ultrasound scans taken at SickKids * New and follow-up patients 0-24 months. Exclusion Criteria: * Older than 24m * Concurrent urinary tract anomalies (duplex configurations; PUV etc.) * History of renal surgical intervention (post-op patients)

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Conditions

The condition(s) this trial relates to.

congenital hydronephrosis hydronephrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hydronephrosis Hydronephrosis congenital

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.