Vital Signs Camera Study

NCT06140433 | Completed

• 1 other identifier: IPS-200169-VSCstudy
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiration Rate; Heart Rate

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 hours

Other Outcomes (2)

• Clinical safety and effectiveness VSC-MEDlib during suboptimal conditions

  2 hours

• Clinical safety and effectiveness VSC-MEDlib during suboptimal conditions

  2 hours

Study Arms (1)

VSC-MEDlib

OTHER

SaMD: Data collection study. Software to be applied after data collection.

Device: VSC-MEDlib

Interventions

VSC-MEDlib DEVICE

VSC-MEDlib will be used for post-processing

VSC-MEDlib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (1)

Philips

Eindhoven, North Brabant, 5656AE, Netherlands

Location

Study Officials

• Murk Westerterp

  Integrated Technology Solutions

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2023
• First Posted: November 20, 2023
• Study Start: February 2, 2024
• Primary Completion: March 15, 2024
• Study Completion: March 15, 2024
• Last Updated: July 5, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)