Performance Study of the Thermodiag Solution for Body Temperature Measurement (ThermodiagPERF)

November 21, 2024 updated by: Daniel DA SILVA, F2D Medical

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Bourg-en-Bresse, France, 01440
      • Charleville-Mezieres, France, 08000
        • Centre Hospitalier Intercommunal - Nord-Ardennes
      • Trappes, France, 78190
        • Hôpital Privé de l'Ouest Parisien
      • Trévenans, France, 90400
        • Hôpital Nord Franche-Comté
        • Contact:
          • julio BADIE, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Temperature Monitor
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Every minute from the enrollment to the end of medical treatment (estimated time : 8 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

F2D Medical

Collaborators

Digital Medical Hub
Clinact Multihealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 26, 2024

Primary Completion (Estimated)

January 30, 2025

Study Completion (Estimated)

March 30, 2025

Study Registration Dates

First Submitted

November 18, 2024

First Submitted That Met QC Criteria

November 21, 2024

First Posted (Estimated)

November 25, 2024

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 21, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-A02014-41_NIFC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Temperature Change, Body

Clinical Trials on Measures performed on all subjects

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe