NCT05640323

Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 37 (actual)
• Sponsor: Norbert Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The study will evaluate the mean average error (MAE) of measuring pulse rate using the Norbert Device (ND) as compared to a reference heart rate measured using an electrocardiogram (ECG).

Detailed description

The study design is to validate the pulse and heart rate accuracy as required per ISO 80601-2-61, Clause 201.12.1.104. The study is a non-randomized, non-blinded single arm design to evaluate the clinical accuracy of the ND's pulse rate measurement compared to a reference heart rate manually measured by observing R-peaks in a standard concurrently recorded ECG from an FDA 510(k)-cleared reference clinical ECG (RCECG). The sponsor will ensure that the study staff enrolls a range of types of arrhythmias including tachycardia, bradycardia, atrial fibrillation, bigeminy, trigeminy, and others.

Conditions

• Healthy
• Arrhythmia

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: 2023-04-26
• Primary completion: 2023-10-04
• Completion: 2023-10-20
• First posted: 2022-12-07
• Last updated: 2023-12-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study