Ignite Creation Date:
2025-12-18 @ 8:19 AM
Ignite Modification Date:
2025-12-23 @ 6:23 PM
Study NCT ID:
NCT05640323
Status:
None
Last Update Posted:
2023-12-20 00:00:00
First Post:
2022-11-28 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
Sponsor:
None
Organization:
Study Overview
Official Title:
Prospective Study to Validate the Clinical Accuracy of the Norbert Device to Measure Pulse Rate
Status:
None
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: