Clinical investigation to validate the accuracy of ThermoFlash®Pro used by health care professionals under real-life conditions
- Conditions
- As this is a medical device, we work according to ISO 80601-2-56 (2017). For thermometers, independent of disease
- Registration Number
- DRKS00032633
- Lead Sponsor
- BIOSYNEX
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 116
Inclusion Criteria
1. Signed and dated informed consent
2. Febrile and non-febrile patients without any age restrictions
Exclusion Criteria
1. Patients who have taken antipyretics in the preceding 120 minutes
2. Patients with medical conditions which might skew Clinical Accuracy Validation results such as inflammation at the measuring site (e.g.: Barbiturates, thyroid preparations, antipsychotics, recent immunizations or intensive sports before the measuring)
3. Current participation in an interventional clinical trial
4. Employees of the sponsor or patients who are employees or relatives of the users
5. Patient with injuries/skin disease at measuring site
6. Pregnant or breastfeeding woman
7. Patient under guardianship or curatorship
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Primary: Evaluation of clinical accuracy of ThermoFlash®Pro<br>- Adverse device effects<br>Timing of data collection: Patients enrolled in the clinical study will be measured for body temperature with Thermoflash® Pro (3x) and RCT (Thermoscan, Braun or rectal thermometer for children under 1 year) by trained nurses who are part of the study team.<br>After each measurements, the information will be recorded on an access-restricted study-specific page in the patient medical record and eCRF<br>
- Secondary Outcome Measures
Name Time Method - Secondary: Rating of the handling of ThermoFlash®Pro