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Clinical Trials/DRKS00032633
DRKS00032633
Completed
N/A

Clinical investigation to validate the accuracy of ThermoFlash®Pro used by health care professionals under real-life conditions

BIOSYNEX0 sites116 target enrollmentSeptember 6, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
As this is a medical device, we work according to ISO 80601-2-56 (2017). For thermometers, independent of disease
Sponsor
BIOSYNEX
Enrollment
116
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 6, 2023
End Date
June 26, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
BIOSYNEX

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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