NCT06140433

Vital Signs Camera Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: Philips Clinical & Medical Affairs Global · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Respiration Rate
• Heart Rate

Interventions

Type	Name	Description
DEVICE	VSC-MEDlib	VSC-MEDlib will be used for post-processing

Timeline

• Start date: 2024-02-02
• Primary completion: 2024-03-15
• Completion: 2024-03-15
• First posted: 2023-11-20
• Last updated: 2024-07-05

Locations

1 site across 1 country: Netherlands