Performance Study of the Thermodiag Solution for Body Temperature Measurement

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-26

Study Completion Date

2025-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Evaluation of Effectiveness of the "Therm'Up" Heating Device

NCT06788925

Hypothermia Due to Cold Environment

ENROLLING_BY_INVITATION NA

Accuracy and Precision Comparison of Temptraq

NCT03264833

Temperature

UNKNOWN

Validation of the Measurement Accuracy of the Tcore Thermometer

NCT04489927

Temperature Change, Body

TERMINATED

Comparison Between Non-invasive Heat-flux and Invasive Core Temperature Monitoring

NCT03368040

Body Temperature Changes

COMPLETED

Does Environmental Factors Affect Accuracy in Pre-hospital Non-invasive Temperature Measurement?

NCT02274597

Hypothermia

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Temperature Change, Body Emergency Department Visit

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, comparative, multi-centre interventional clinical investigation

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Sponsor

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Measures performed on all subjects

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No