Study on the validation of the medical, contactless infrared clinical thermometer GCE 107 Contactless Infrared Thermometer for measuring body temperature according to DIN EN ISO 80601-2-56 [1]

Study on the validation of the medical, contactless infrared clinical thermometer GCE 107 Contactless Infrared Thermometer for measuring body temperature according to DIN EN ISO 80601-2-56 [1] - Validation of the GCE 107 Contactless Infrared Thermometer

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00029978

Enrollment

105

Registered

2023-02-09

Start date

2023-11-08

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Validation of the GCE 107 Contactless Infrared Thermometer

Interventions

Group 1: At least 105 subjects with three valid measurements each with the test device (TUT) and at least one with a reference device (RCT).

Eligibility

Sex/Gender

All

Age

0 Months to No maximum

Inclusion criteria

Inclusion criteria: Subjects from 0 months and 2.5 kg body weight, subjects or their parents or legal representatives must have signed an informed consent form prior to study participation.

Exclusion criteria

Exclusion criteria: Disability and/or other circumstances due to which the subject is unable to understand the nature, significance and scope of the study. In the case of minors, parental permission to participate may be given. Pregnancy

Design outcomes

Primary

Measure	Time frame
The aim of the validation study is to demonstrate the clinical measurement accuracy of the GCE 107 Contactless Infrared Thermometer for patients of all age groups as well as for the overall population.	—

Countries

Germany

Contacts

Public ContactHolger Köster

Klinikum Oldenburg AöR, Fachbereich Pädiatrische Pneumologie und Allergologie

koester.holger@klinikum-oldenburg.de+494414032028

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026