Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-02 @ 5:52 PM
Study NCT ID:
NCT06140433
Status:
COMPLETED
Last Update Posted:
2024-07-05
First Post:
2023-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vital Signs Camera Study
Sponsor:
Philips Clinical & Medical Affairs Global
Organization:
Study Overview
Official Title:
Vital Signs Camera Study
Status:
COMPLETED
Status Verified Date:
2024-07
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:
VSC
Brief Summary:
This study is a single center, prospective clinical investigation which is balanced for gender, age, Body Mass Index (BMI) and skin color. Simultaneous measurements of PR and RR on study participants will be collected in conditions described in IFU and various suboptimal conditions. The study participants will be recorded with the VSC demo app (together with a compatible camera and computing hardware) and reference devices. PR and RR data to be collected by the VSC demo app, will be post-processed after the clinical investigation and compared with the reference devices. Persons who are willing to participate will be asked to provide their consent.
Primary objective:
• To assess the clinical safety and effectiveness of Pulse Rate (PR) and Respiration Rate (RR) measured with the VSC-MEDlib within the intended use compared to the gold-standard reference devices.
Exploratory objective:
• To assess the clinical safety and effectiveness of Pulse Rate and Respiration Rate measured with the VSC-MEDlib during suboptimal circumstances (outside the scope of the intended use), compared to the gold-standard reference devices.
Primary objective:
• To assess the clinical safety and effectiveness of Pulse Rate (PR) and Respiration Rate (RR) measured with the VSC-MEDlib within the intended use compared to the gold-standard reference devices.
Exploratory objective:
• To assess the clinical safety and effectiveness of Pulse Rate and Respiration Rate measured with the VSC-MEDlib during suboptimal circumstances (outside the scope of the intended use), compared to the gold-standard reference devices.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: