N/A
Completed N=86
A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients
Vital Sign Evaluation
Source: ClinicalTrials.gov NCT05853380 ↗
Enrolled (actual)
86
Serious AEs
0.0%
Results posted
Nov 2025
Primary outcomePrimary: Pulse Rate Accuracy — 67 Participants
Summary
Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform Description This single-arm cohort, open-label, and multi-center study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including pulse rate (PR). It is hypothesized that the accuracy of the App is non-inferior to the accuracy of an FDA-cleared/approved vital sign monitoring device (reference device).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pulse Rate Accuracy |
67 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects 22 -85 years of age
- Subjects willing to sign the Informed Consent Form and comply with the protocol
Exclusion Criteria
- Subjects required to wear mask or bandage that obstructs forehead, cheeks, or chin
- Refusal to remove makeup , sunscreen, lotion, clothing, or items obstructing the face for the duration of measurement
- Presence of facial tattoos, large birthmarks, or other skin alterations (scars, hemangiomas, vitiligo) on upper cheeks (cheekbone) or forehead of the subject
- Condition that does not allow the subject to remain still for 60 seconds at a time
- Subjects with cardiac arrhythmia
- Any known medical condition which may result in an inaccurate measurement using the reference device
- Subjects with the inability to complete an ECG.
Data sourced from ClinicalTrials.gov (NCT05853380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.