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NCT Number: NCT06703931

Performance Study of the Thermodiag Solution for Body Temperature Measurement

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).

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier De Fleyriat, Bourg-en-Bresse, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;
  • Pregnant or breast-feeding women.

Treatment and study plan

Measures performed on all subjects

Device

In intensive care Medics will use a reference medical device and Thermodiag®. Simultaneous and synchronised measurements will be taken every minute.

Primary outcomes

  1. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Benjamin MENARD, PhD

CONTACT

[email protected]

+33658918607

Sponsors and collaborators

Lead sponsor

F2D Medical

Industry

Collaborators

  • Clinact Multihealth
  • Digital Medical Hub

Registry information

Official study 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

Acronym: ThermodiagPERF

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 25, 2024
Registry last updated
Nov 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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