Performance Study of the Thermodiag Solution for Body Temperature Measurement (NCT06703931) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Performance Study of the Thermodiag Solution for Body Temperature Measurement
France60 participantsStarted 2024-11-26
Plain-language 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).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients aged 18 to 80 years;
* Female or male patients;
* Patients hospitalised in a critical care unit as defined by the Public Health Code of the Republic of France, Article R6123-33: 'The critical care activity consists of the care of patients who present or are likely to present one or more acute failures directly threatening the vital or functional prognosis and which may require recourse to one or more methods of substitution'.
* Patients affiliated to the social security system or beneficiaries of such a system, where applicable, in accordance with local regulations;
* Voluntary patients - or trusted person/family member/relative who have given oral and written consent after being informed by the investigator of the research.
Exclusion Criteria:
* Patients with a corpulence or physical characteristics responsible for a 'tourniquet' effect: arm circumference greater than 47 centimetres;
* Patients with burns on the arm (location for Thermodiag® measurement);
* Patients with particularly sensitive or affected skin in the biceps or armpit (left and right);
* Patients undergoing an MRI examination;
* Patients undergoing extracorporeal circulation;
* Patients with a history of allergy to silicone;
* Patients with active implantable medical devices such as pacemakers, defibrillators, etc. ;
* Patients undergoing dialysis;
* Patients with a tattoo in the area where the investigational device will be worn (arm);
* Patients currently excluded from anot…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Body temperature Measurement
Timeframe: Every minute from the enrollment to the end of medical treatment (estimated time : 8 days)