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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Antonius Hospital

About this trial

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).

Eligibility criteria

Qualifiers

Age 18 years or older.

Suspected or confirmed hereditary hemorrhagic telangiectasia (HHT).

Incidentally: Patients who have experienced cryptogenic stroke

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Transcranial Ultrasound Device

Treatment groups

40 Participants
are divided into 1 treatment group

Sponsors and collaborators

St. Antonius Hospital

Lead sponsor

Burl Concepts, Inc.

Collaborator