NCT06703931

Performance Study of the Thermodiag Solution for Body Temperature Measurement

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: F2D Medical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Temperature Change, Body
• Emergency Department Visit

Interventions

Type	Name	Description
DEVICE	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.

Timeline

• Start date: 2024-11-26
• Primary completion: 2025-01-30
• Completion: 2025-03-30
• First posted: 2024-11-25
• Last updated: 2024-11-25

Locations

4 sites across 1 country: France