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OpenTrials
Completed

NCT Number: NCT06140433

Vital Signs Camera Study

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.

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Key information

Conditions

Respiration Rate Heart Rate

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Philips

Eindhoven, North Brabant, 5656AE, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Persons with ASA I or II classification
  • Adult population (age >18 years old)
  • BMI ≥ 18 - ≤ 40 kg/m2
  • Able to intensively exercise for 10 minutes
  • Persons willing to give informed consent
  • Willingness to have vital signs measured by a medical mobile application
  • Willingness to follow study protocol (e.g., put on sunglasses, facial make-up, medical face-mask and sitting still up to 2 minutes)

Exclusion criteria

  • Vulnerable populations (e.g., age <18 years old, not able to consent by themselves, or immunecompromised or pregnant women)
  • Cardiac arrhythmias (e.g., Atrial Fibrillation, Supraventricular Tachycardia, Ventricular arrhythmia, regular ectopic beats)
  • Persons present signs of infection
  • Participant has known allergic reactions to make-up and/or make-up remover
  • Persons with positive COVID 19 test in last 14 days
  • Participant who exhibit irregular or excessive movement such as tremors, tics, shaking and/or shivering
  • Participant is Philips employee or their family members residing with this Philips employee.

Treatment and study plan

VSC-MEDlib

Device

VSC-MEDlib will be used for post-processing

Primary outcomes

  1. Clinical safety and effectiveness VSC-MEDlib according to IFU

    Time frame: 2 hours

    Clinical safety and effectiveness of the non-invasive and contactless measurement RR by the VSC-MEDlib within the intended use.

  2. Clinical safety and effectiveness VSC-MEDlib according to IFU

    Time frame: 2 hours

    Clinical safety and effectiveness of the non-invasive and contactless measurement of PR by the VSC-MEDlib within the intended use.

Other outcomes

  1. Clinical safety and effectiveness VSC-MEDlib during suboptimal conditions

    Time frame: 2 hours

    Safety and clinical effectiveness during suboptimal conditions, in RMSE, availability, and precision of the non-invasive and contactless measurement of RR by the VSCMEDlib.

  2. Clinical safety and effectiveness VSC-MEDlib during suboptimal conditions

    Time frame: 2 hours

    Safety and clinical effectiveness during suboptimal conditions, in RMSE, availability, and precision of the non-invasive and contactless measurement of PR by the VSCMEDlib.

Sponsors and collaborators

Lead sponsor

Philips Clinical & Medical Affairs Global

Industry

Registry information

Acronym: VSC

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 20, 2023
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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