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Performance Study of the Thermodiag Solution for Body Temperature Measurement

NCT06703931 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-11-25

No results posted yet for this study

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).

Conditions

  • Temperature Change, Body
  • Emergency Department Visit

Interventions

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.

Sponsors & Collaborators

  • Clinact Multihealth

    collaborator UNKNOWN

  • Digital Medical Hub

    collaborator OTHER

  • F2D Medical

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-26
Primary Completion
2025-01-30
Completion
2025-03-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06703931 on ClinicalTrials.gov