Trials / Withdrawn
WithdrawnNCT05640310
Prospective Study to Validate the Clinical Accuracy of Norbert Device to Measure Body Temperature
- Status
- Withdrawn
- Phase
- —
- Study type
- Observational
- Enrollment
- 0 (actual)
- Sponsor
- Norbert Health · Industry
- Sex
- All
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
The study will evaluate the clinical bias and clinical repeatability of measuring body temperature using the Norbert Device (ND).
Detailed description
The study design is based on the ISO 80601-2-56, Clause 201.102 for adjusted mode clinical thermometers. The study is designed to be a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's temperature measurement compared to a standard FDA 510(k)-cleared reference clinical thermometer (RCT).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Norbert Device | The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate. |
Timeline
- Start date
- 2023-03-01
- Primary completion
- 2023-07-01
- Completion
- 2023-07-01
- First posted
- 2022-12-07
- Last updated
- 2023-08-24
Source: ClinicalTrials.gov record NCT05640310. Inclusion in this directory is not an endorsement.