Contactless Ultrasound Data Acquisition in Emergency Departments to Discriminate the Origin of Dyspnea and Chest Pain
Starting soon
Conditions studied: Dyspnea, Chest Pain
In brief
PAnDA-One is a prospective, multicenter, interventional study (10 centers, France) aimed at developing and validating a diagnostic support algorithm based on the ADx-One medical device, which non-invasively acquires thoracic vibrations using airborne ultrasound. The study will enroll 2,500 patients presenting to the emergency department with acute dyspnea or non-traumatic chest pain, divided into a development cohort (N = 1,500) and an independent test cohort (N = 1,000). The deep learning algorithm will be trained to discriminate cardiovascular from non-cardiovascular origins of symptoms, and its performance will be assessed by AUROC, sensitivity, and specificity against a final diagnosis established by an expert adjudication committee. Patient management will not be modified by study participation.
Key facts
- Study ID
- NCT07653204
- Run by
- Austral Diagnostics
- People needed
- 2500
- Starts
- 2026-09-01
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Presentation to the emergency department for one or more of the following symptoms of less than 14 days' duration: acute non-traumatic dyspnea, or recent worsening of chronic dyspnea, or non-traumatic chest pain.
- Patient able to sit on a chair or on the edge of the bed
- Affiliation to national health insurance
- Able to receive study information, understand the study, and provide written informed consent
You may not qualify if…
- • Immediate need for life-saving intervention or clinical instability incompatible with study procedures.
- Shock or severe hemodynamic instability, for example systolic blood pressure <90 mmHg for at least 30 minutes or associated signs of hypoperfusion.
- Altered mental status or any condition preventing provision of valid informed consent.
- Known cognitive impairment preventing informed consent.
- Transfer to another care site before the ADx-One acquisition can be performed.
- Known pregnancy
- Minor, legally protected adult, or person deprived of liberty.
- Participation in another interventional clinical study judged incompatible with this study.
Where it is running
- La Pitié-Salpêtrière — Paris, France
Full record on ClinicalTrials.gov
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