Respiration RateVSCNCT06140433
Vital Signs Camera Study
A study testing VSC-MEDlib in people with Respiration Rate and Heart Rate, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiration Rate, Heart Rate
- What is being tested?
- VSC-MEDlib
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Feb 2024to 15 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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:
Read more
- 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
- Being tested
- VSC-MEDlib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VSC-MEDlibDevice
VSC-MEDlib will be used for post-processing
| Study group | Role | What they receive |
|---|---|---|
| VSC-MEDlib | Other | SaMD: Data collection study. Software to be applied after data collection. Receives: Device: VSC-MEDlib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start2 Feb 2024
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiration RateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Murk Westerterp, Study director, Integrated Technology Solutions
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140433
- Sponsor's protocol ID
- IPS-200169-VSCstudy
- Acronym
- VSC
- Status last verified
- Jul 2024
- First submitted
- 11 Oct 2023
- Last updated
- 5 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vital Signs Camera Study
- ClinicalTrials.gov ID
- NCT06140433
- Acronym / sponsor ID
- VSC / IPS-200169-VSCstudy
- Conditions
- Respiration Rate, Heart Rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 20 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VSC-MEDlib | Other | Device: VSC-MEDlibSaMD: Data collection study. Software to be applied after data collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VSC-MEDlibVSC-MEDlib will be used for post-processing | Device | VSC-MEDlib |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Murk Westerterp study director
Integrated Technology Solutions
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VSC-MEDlib in people with Respiration Rate and Heart Rate, run by Philips Clinical & Medical Affairs Global at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical safety and effectiveness VSC-MEDlib according to IFU (time frame: 2 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.