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Performance Study of the Thermodiag Solution for Body Temperature Measurement | Clinical Trials | Clareo Health

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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

NCT06703931•F2D Medical

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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 another protocol or taking part in another interventional research study;
+1 more criteria

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

Key Dates

Start Date

November 26, 2024

Primary Completion Date

January 30, 2025

Completion Date

March 30, 2025

Last Updated

November 25, 2024

Enrollment

ESTIMATED participants

Conditions

Temperature Change, BodyEmergency Department Visit

Interventions

Measures performed on all subjects

DEVICE

Contacts

Benjamin MENARD, PhD

CONTACT

+33658918607 b.menard@f2d-medical.fr

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 25, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Performance Study of the Thermodiag Solution for Body Temperature Measurement

Inclusion Criteria

Exclusion Criteria

Referral of Patients With Biological Abnormalities to an Emergency Department

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