Noninvasive Detection of Pulmonary Right to Left Shunts Using the

By Dr. Hatem Rabeh · Published February 17, 2026 · Updated March 16, 2026

Meta description A regulatory news item on a noninvasive method to detect pulmonary right to left shunts using the SONAS ultrasound device. The report summarizes study scope participant criteria device function sponsor details and current recruitment status as of February 19 2026.

Published on February 19 2026 this briefing covers a clinical trial that evaluates a noninvasive approach to identify right to left shunts in the lungs or at the cardiac level using a transcranial ultrasound device. The study intersects conditions such as hereditary haemorrhagic telangiectasia PFO and pulmonary arteriovenous malformations. The information is drawn from ClinicalTrials.gov record NCT07414446 and related sponsor disclosures. The evaluation aims to determine whether this transcranial ultrasound device can assist in detecting shunts without invasive procedures while informing risk assessment and patient management in selected populations. The trial is listed as recruiting with sponsors St Antonius Hospital and Burl Concepts Inc and the official trial link is provided here https //clinicaltrials.gov/study/NCT07414446?term=medical+device.

In this article we examine what changed in the regulatory landscape for a device driven noninvasive screening method to detect pulmonary shunts. Readers should note that the device name SONAS is referenced as a transcranial ultrasound device in the study record. This article presents the facts as described in the source text and aligns with MDR Annex XIV style by stating intended purpose and the context of use as reported by sponsors investigators and trial registries. The content below is intended for clinical quality regulatory teams and device professionals examining noninvasive diagnostic approaches in a regulatory framework.

In this article we provide a compact navigation block to help readers jump to sections of interest. In this article In this article What is the study about What is the study design and who can participate How does the SONAS ultrasound device work for this indication Who sponsors and where is the trial conducted FAQ Conclusion Disclaimer Announcement line

In this article What is the study about | What is the study design and who can participate | How does the SONAS ultrasound device work for this indication | Who sponsors and where is the trial conducted | FAQ

What is the study about

The ClinicalTrials.gov record NCT07414446 describes a noninvasive approach to detect pulmonary right to left shunts using a transcranial ultrasound device. The investigation focuses on conditions associated with abnormal shunting including hereditary haemorrhagic telangiectasia and cardiac or pulmonary right to left shunts such as patent foramen ovale and pulmonary arteriovenous malformations. The intervention is a transcranial ultrasound device and the study aims to determine whether this technology can identify shunts without invasive testing thereby contributing to screening and diagnostic pathways in affected patients. The information presented here reflects the source material and does not constitute a claim of device performance beyond the registry entry.

Focus on conditions

Hereditary haemorrhagic telangiectasia is highlighted as a potential context for shunt risk and screening. Patent foramen ovale is cited as an intracardiac route for right to left shunting. Pulmonary arteriovenous malformations are listed as a pulmonary mechanism that may contribute to shunt physiology. The study seeks to clarify whether a noninvasive ultrasound based approach can support clinical decision making in these scenarios.

What is the study design and who can participate

The record confirms recruitment for the trial and identifies St Antonius Hospital and Burl Concepts Inc as sponsors. Specific design details such as randomization or sample size are not described in the provided source text. The absence of detailed protocol information means readers should consult the ClinicalTrials.gov entry for complete methodology and updated status as the trial progresses. This section summarizes the available information while maintaining a regulatory and evidence based stance suitable for quality teams and regulatory professionals.

How does the SONAS ultrasound device work for this indication

The SONAS device is described in the registry as a transcranial ultrasound device used in an investigative capacity to detect pulmonary right to left shunts noninvasively. In this context the device is positioned as an aid in identifying shunt presence without catheter based testing. The available material does not provide performance metrics such as sensitivity or specificity. Stakeholders should rely on sponsor documentation and trial reports for formal device claims and regulatory status.

Who sponsors and where is the trial conducted

Sponsors listed for this study are St Antonius Hospital and Burl Concepts Inc. The available source text does not specify trial locations beyond sponsor information. As the record indicates recruitment the trial status should be periodically reviewed on ClinicalTrials.gov for site details and regulatory updates. Readers should use the link provided to verify current information and obtain access to the official trial record.

Conclusion and implications for readers

The current status shows recruitment is ongoing under sponsor oversight. For regulated professionals the key takeaway is that a noninvasive transcranial ultrasound approach to detect pulmonary right to left shunts is being explored within a defined clinical context. Regulators and manufacturers should monitor updates to protocol design safety performance and labeling claims as the study evolves. The information herein is derived from the registry and sponsor notes and should not be interpreted as a completed validation of device utility.