An interventional study of VSC-MEDlib in Respiration Rate and Heart Rate, sponsored by Philips Clinical & Medical Affairs Global. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.
Sponsored by Philips Clinical & Medical Affairs Global (part of Philips) · Not applicable, Interventional, and Screening
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:
Exploratory objective:
Philips Clinical & Medical Affairs Global is the lead sponsor of 84 studies on the registry; 24 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
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Exclusion Criteria:
SaMD: Data collection study. Software to be applied after data collection.
Device: VSC-MEDlib
VSC-MEDlib will be used for post-processing
Clinical safety and effectiveness VSC-MEDlib according to IFU
Clinical safety and effectiveness of the non-invasive and contactless measurement RR by the VSC-MEDlib within the intended use.
Time frame: 2 hours
Clinical safety and effectiveness VSC-MEDlib according to IFU
Clinical safety and effectiveness of the non-invasive and contactless measurement of PR by the VSC-MEDlib within the intended use.
Time frame: 2 hours
Clinical safety and effectiveness VSC-MEDlib during suboptimal conditions
Safety and clinical effectiveness during suboptimal conditions, in RMSE, availability, and precision of the non-invasive and contactless measurement of RR by the VSCMEDlib.
Time frame: 2 hours
Clinical safety and effectiveness VSC-MEDlib during suboptimal conditions
Safety and clinical effectiveness during suboptimal conditions, in RMSE, availability, and precision of the non-invasive and contactless measurement of PR by the VSCMEDlib.
Time frame: 2 hours
Plan to share: No
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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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