Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07414446

Non-Invasive Detection of Pulmonary Right-to-Left Shunts Using the SONAS Ultrasound Device

Led by St. Antonius Hospital · Updated on 2026-02-17

40

Participants Needed

1

Research Sites

12 weeks

Total Duration

On this page

Sponsors

S

St. Antonius Hospital

Lead Sponsor

B

Burl Concepts, Inc.

Collaborating Sponsor

AI-Summary

What this Trial Is About

The goal of this clinical trial is to learn how well the SONAS ultrasound device can detect right-to-left shunts of adults with hereditary hemorrhagic telangiectasia (HHT) who are already scheduled for a contrast bubble echocardiogram (TTCE). The main questions it aims to answer are: 1. How accurately does SONAS detect right-to-left shunts compared to the standard TTCE test? 2. Can SONAS results help tell the difference between shunts in the heart and shunts in the lungs? Participants will wear a headband with the SONAS device on the head while they undergo their routine TTCE bubble test. They will receive the usual contrast (agitated saline) through a vein, and both SONAS and TTCE signals will be recorded at the same time. There will be one examination in rest, and one during a breathing exercise (the Valsalva manoeuvre).

CONDITIONS

Official Title

Non-Invasive Detection of Pulmonary Right-to-Left Shunts Using the SONAS Ultrasound Device

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Suspected or confirmed hereditary hemorrhagic telangiectasia (HHT)
  • Patients who have experienced cryptogenic stroke (incidental)
Not Eligible

You will not qualify if you...

  • Pregnancy or breastfeeding
  • Known or suspected fractures of the temporal or parietal skull bones, or open skin injuries in those areas
  • Known metal skull implants or head/ear anatomy that prevents proper headset placement
  • Known allergies or reactions to parabens in the gel pad material

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands, 3435CM

Actively Recruiting

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Research Team

P

Pier HJ van Veen, Medical Doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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