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Performance Study of the Thermodiag Solution for Body Temperature Measurement
Sponsor: F2D Medical
Summary
The goal of this prospective, comparative, multi-centre interventional clinical investigation, is to evaluate the performance of the Thermodiag® medical device, compared with reference methods, for continuous measurement of core temperature in critical care patients. The main question it aims to answer is to develop non-invasive alternatives to the current methods of measuring core body, to reduce health risks, and overcome various other limitations (as infection, bleeding, thrombosis and local reactions).
Official title: Evaluation of PERThermodiag® Medical Device for CT Temperature Measurement and Anomaly Detection Compared to Reference Methods in Critical Care Hospitalized Patients: a Comparative, Multi-center Interventional Study
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2024-11-26
Completion Date
2025-03-30
Last Updated
2024-11-25
Healthy Volunteers
No
Interventions
Measures performed on all subjects
In intensive care Medics will use a reference medical device and Thermodiag®. Simultaneous and synchronised measurements will be taken every minute.
Locations (4)
Centre Hospitalier De Fleyriat
Bourg-en-Bresse, France
Centre Hospitalier Intercommunal - Nord-Ardennes
Charleville-Mézières, France
Hôpital Privé de l'Ouest Parisien
Trappes, France
Hôpital Nord Franche-Comté
Trévenans, France