Clinical Trial

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

Study acronym: SONAS
Recruiting
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Record status
This record was last updated February 17, 2026 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
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).
Trial Details
NCT Number NCT07414446
Lead Sponsor St. Antonius Hospital
Collaborators: Burl Concepts, Inc.
Conditions Hereditary Haemorrhagic Telangiectasia, PFO - Patent Foramen Ovale, Pulmonary Arteriovenous Malformation
Enrollment 40 participants
Start Date 2026-01-07
Primary Completion 2026-04-01 (estimated)
Study Completion 2026-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-17