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NOT YET RECRUITING
NCT07653204

Contactless Ultrasound Data Acquisition in Emergency Departments to Discriminate the Origin of Dyspnea and Chest Pain

Sponsor: Austral Diagnostics

View on ClinicalTrials.gov

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.

Official title: Prospective Study for Data Acquisition in Emergency Departments to Develop a Discrimination Algorithm for the Origin of Dyspnea and Chest Pain Using the ADx-One Medical Device

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

2500

Start Date

2026-09

Completion Date

2027-05

Last Updated

2026-06-17

Healthy Volunteers

No

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.

Locations (1)

La Pitié-Salpêtrière

Paris, France