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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-26

Study Completion Date

2023-10-20

Brief Summary

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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

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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

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Healthy Arrhythmia

Keywords

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medical device validation arrhythmia ECG pulse rate Norbert Device Norbert Health

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Norbert Device

The Norbert Device (ND) is a contactless, noninvasive device that provides measurements of body temperature, oxygen saturation (SpO2), and pulse rate.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male or female subjects aged 18 or over
* Ability to provide signed informed consent

Exclusion Criteria

* Pregnant
* Otherwise deemed unsuitable to participate in the study based on judgment of the study investigator

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Locations

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Newlab

Brooklyn, New York, United States

Site Status

Staten Island University Hospital

Staten Island, New York, United States

Site Status

Countries

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United States

Other Identifiers

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NCP-0002

Identifier Type: -

Identifier Source: org_study_id