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

RecruitingNAAges 18 Years - anyAllSt. Antonius Hospital
NCT07414446 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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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What it tests

  • Transcranial Ultrasound Device
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Where

1 site
St. Antonius Hospital
Nieuwegein, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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