Temperature Change, BodyThermodiagPERFNCT06703931
Performance Study of the Thermodiag Solution for Body Temperature Measurement
A study testing Measures performed on all subjects in people with Temperature Change, Body and Emergency Department Visit, run by F2D Medical at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Temperature Change, Body, Emergency Department Visit
- What is being tested?
- Measures performed on all subjects
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesFrance
- Study dates
- 26 Nov 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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 another protocol or taking part in another interventional research study;
- Pregnant or breast-feeding women.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites
Centre Hospitalier De Fleyriat
Bourg-en-Bresse, 01440
Laurence MINNE, +33474454184, lminne@ch-bourg01.fr
Sylvie Roux, sroux@ch-bourg01.fr
Centre Hospitalier Intercommunal - Nord-Ardennes
Charleville-Mézières, 08000
Hôpital Privé de l'Ouest Parisien
Trappes, 78190
Hôpital Nord Franche-Comté
Trévenans, 90400
Pascal MATHIS, +33675629068, pascal.mathis@hfnc.fr
Elodie BOUVIER, +33675629068, elodie.bouvier@hfnc.fr
About this study
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
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).
- Being tested
- Measures performed on all subjects
- Keywords
- Temperature, Body temperature, Monitoring temperature, multisensors, Actimetry, Actigraphy, Heart rate, Continuous measurement, Contextualized measure, Dedicated machine learning model, Machine Learning
- Medical subject headings
- Body Temperature Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measures performed on all subjectsDevice
In intensive care Medics will use a reference medical device and Thermodiag®. Simultaneous and synchronised measurements will be taken every minute.
| Study group | Role | What they receive |
|---|---|---|
| Temperature Monitor | Experimental | 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. Receives: Device: Measures performed on all subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Every minute from the enrollment to the end of medical treatment (estimated time : 8 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2024
- Study start26 Nov 2024 (estimated)
- Primary completion30 Jan 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temperature Change, BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, comparative, multi-centre interventional clinical investigation
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- F2D Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clinact Multihealth, Digital Medical Hub
- Responsible party
- Principal investigator, Daniel DA SILVA, Delafontaine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06703931
- Sponsor's protocol ID
- 2023-A02014-41_NIFC
- Acronym
- ThermodiagPERF
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 25 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06703931
- Acronym / sponsor ID
- ThermodiagPERF / 2023-A02014-41_NIFC
- Keywords
- Temperature, Body temperature, Monitoring temperature, multisensors, Actimetry, Actigraphy, Heart rate, Continuous measurement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- F2D MedicalIndustry (pharma, biotech, devices)
- Collaborators
- Clinact Multihealth, Digital Medical Hub
- Study start
- 26 Nov 2024 (estimated)
- Primary completion
- 30 Jan 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 25 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, comparative, multi-centre interventional clinical investigation
| Arm | Type | Receives |
|---|---|---|
| Temperature Monitor | Experimental | Device: Measures performed on all subjectsPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measures performed on all subjectsIn intensive care Medics will use a reference medical device and Thermodiag®. Simultaneous and synchronised measurements will be taken every minute. | Device | Temperature Monitor |
Primary outcome
Body temperature Measurement
Time frame: Every minute from the enrollment to the end of medical treatment (estimated time : 8 days)
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2024.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measures performed on all subjects in people with Temperature Change, Body and Emergency Department Visit, run by F2D Medical at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin MENARD, PhD (+33658918607, b.menard@f2d-medical.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body temperature Measurement (time frame: Every minute from the enrollment to the end of medical treatment (estimated time : 8 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2024.