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Can a new imaging device see inside the brain to spot hydrocephalus?

NCT ID NCT07784179

Diagnosis Sponsor: Michael McDowell 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This study is testing a combined photoacoustic and ultrasound (PAUS) imaging device to see if it can help diagnose hydrocephalus in infants and children. Hydrocephalus is a condition where fluid builds up in the brain, and current diagnosis often relies on other imaging methods. The study will measure how well the PAUS device can image the brain before and after treatment, and whether it can confirm that treatments are working. Participants will undergo imaging sessions through the soft spot on the head, each lasting 30 to 60 minutes.

What this could mean

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

Active substance
Photoacoustic and ultrasound (PAUS) imaging device
What this could lead to
If successful, this could provide a faster, safer, and more accurate way to diagnose hydrocephalus in children and to confirm that treatments are working, potentially reducing the need for more invasive procedures.
What could go wrong
This is an early-stage study focused on measuring imaging capabilities, not on treating the condition. The device may not perform well enough in practice, and results may not apply to all children with hydrocephalus.

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 250 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2029

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 days to 3 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: * Diagnosis of hydrocephalus by a neurosurgeon * Age ≤ 3 years * Admitted to Penn State Health Children's Hospital with plans for definitive hydrocephalus treatment while inpatient, including shunt placement surgery, endoscopic third ventriculostomy, shunt revision, external ventricular drain placement. Exclusion Criteria: * Age \> 3 years * No open anterior fontanelle or fontanelle is obstructed for clinical purposes * Too unstable to undergo diagnostic testing equivalents (i.e. standard ultrasonography)

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Conditions

The condition(s) this trial relates to.

hydrocephalus

As listed by the trial registrant

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

Hydrocephalus in children Hydrocephalus in infants

How to take part

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  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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.

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