Contactless Ultrasound Data Acquisition in Emergency Departments to Discriminate the Origin of Dyspnea and Chest Pain
NCT07653204 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 2500
Last updated 2026-06-17
Summary
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.
Conditions
Interventions
- DEVICE
-
All patients from both groups will be imaged with airborne ultrasound device
Patients from both cohorts will follow their usual routine, except for stepping in front of the machine so that one or two images of their chest and back can be taken.
Sponsors & Collaborators
-
Austral Diagnostics
lead INDUSTRY
Principal Investigators
-
Yonathan Freund, Professor · Assistance Publique - Hôpitaux de Paris
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-30
- Primary Completion
- 2027-05-31
- Completion
- 2027-05-31
Countries
- France
Study Locations
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