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Headband device could spot hidden shunts without needles

NCT ID NCT07414446

Diagnosis Sponsor: St. Antonius Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a head-worn ultrasound device called SONAS that listens for bubble signals in the brain during a standard heart ultrasound. It aims to see if the device can accurately detect right-to-left shunts—abnormal connections between blood vessels—in adults with hereditary hemorrhagic telangiectasia (HHT). Participants wear the headband while getting a routine bubble echo test, and the device's readings are compared to the standard test results.

What this could mean

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

Active substance
Transcranial Ultrasound Device (SONAS)
What this could lead to
If successful, this device could offer a simpler, non-invasive way to detect and distinguish heart vs. lung shunts, potentially reducing the need for more invasive tests.
What could go wrong
This is a small, early-stage study (40 participants) focused on diagnostic accuracy. The device may not prove reliable enough to replace standard methods, and results may not apply to broader populations.

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 40 people

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

Started

Jan 2026

Expected to finish

Apr 2026

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

18 years and older

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: * Age 18 years or older. * Suspected or confirmed hereditary hemorrhagic telangiectasia (HHT). * Incidentally: Patients who have experienced cryptogenic stroke Exclusion Criteria: * Pregnancy or breastfeeding. * Known or suspected fracture(s) of the temporal / parietal skull bones, or with open skin injuries in the anatomical area of the temporal / parietal lobes. * Patients with known metal skull implants in the anatomical area of the temporal / parietal bones, or with anatomical formation of the head or ear tha may interfere with proper headset placement. * Patients with known allergies or reactions to parabens, which are present in the gel pad material of the applied part.

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Conditions

The condition(s) this trial relates to.

arteriovenous hemangioma/malformation hereditary hemorrhagic telangiectasia Ischemic Stroke patent foramen ovale Pulmonary Arteriovenous Fistulas

As listed by the trial registrant

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

Hereditary haemorrhagic telangiectasia Pfo - patent foramen ovale Pulmonary arteriovenous malformation

How to take part

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

  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.

    Open the record ↗

  3. 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

  • St. Antonius Hospital

    RECRUITING

    Nieuwegein, Utrecht, 3435CM, Netherlands

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