Vital Signs Camera Study

NCT ID: NCT06140433

Last Updated: 2024-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-02
• Study Completion Date: 2024-03-15

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

VSC-MEDlib

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

Group Type: OTHER

VSC-MEDlib

Intervention Type: DEVICE

VSC-MEDlib will be used for post-processing

Interventions

VSC-MEDlib

VSC-MEDlib will be used for post-processing

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Murk Westerterp

Role: STUDY_DIRECTOR

Integrated Technology Solutions

Locations

Philips

Eindhoven, North Brabant, Netherlands

Countries

Netherlands

Other Identifiers

IPS-200169-VSCstudy

Identifier Type: -

Identifier Source: org_study_id