An interventional study of Measures performed on all subjects in Temperature Change, Body and Emergency Department Visit, sponsored by F2D Medical. Not yet recruiting at 4 sites in France. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by F2D Medical · Not applicable, Interventional, and Other
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).
97 studies on the registry are indexed under Body Temperature Changes; 20 are open to participants now.
This study's planned enrollment of 60 is above the median of 40 across 68 interventional studies indexed under Body Temperature Changes.
Browse Body Temperature Changes studies →This is the only study on the registry with F2D Medical as lead sponsor.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients included in the study will have their temperature measured simultaneously during their stay in intensive care, with Thermodiag(R) and with the reference medical device.
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.
Body temperature Measurement
The degree of agreement between the two medical devices (Thermodiag® versus reference method in the hospital unit) will be assessed (expected measure is less than 0.1°C).
Time frame: Every minute from the enrollment to the end of medical treatment (estimated time : 8 days)
Plan to share: No — According to GDPR Regulation 2016, patients data are sensitive. Sponsor is requirred to return them to facilities or to destroy them. That's why no patients data are planed to be shared.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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