Vital Sign EvaluationNCT05853380
A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients
An observational study of Vital Sign Evaluation, run by Mindset Medical at 6 sites in United States.
Trial summary
Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform Description This single-arm cohort, open-label, and multi-center study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including pulse rate (PR). Read more about this study
- Who is it for?
- Ages 22 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Vital Sign Evaluation
- What is being tested?
- Informed Vital Core App
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 6 sitesUnited States
- Study dates
- 2 Jun 2023to 29 Jun 2023
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 22 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will recruit subjects from clinics and hospitals and the general public. Enrollment of 85 subjects with an age range of 22-85 years of age with a wide range of skin tone categorization per the Fitzpatrick Scale ranging from 1-6.
Who may be able to join
- Subjects 22 -85 years of age
- Subjects willing to sign the Informed Consent Form and comply with the protocol
Who cannot join
- Subjects required to wear mask or bandage that obstructs forehead, cheeks, or chin
- Refusal to remove makeup , sunscreen, lotion, clothing, or items obstructing the face for the duration of measurement
- Presence of facial tattoos, large birthmarks, or other skin alterations (scars, hemangiomas, vitiligo) on upper cheeks (cheekbone) or forehead of the subject
- Condition that does not allow the subject to remain still for 60 seconds at a time
- Subjects with cardiac arrhythmia
- Any known medical condition which may result in an inaccurate measurement using the reference device
- Subjects with the inability to complete an ECG.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Velocity Clinical Research
Cedar Park, Texas, 78613
Velocity Clinical Research
Cleveland, Ohio, 44122
Velocity Clinical Research
Columbia, South Carolina, 29204
Velocity Clinical Research
La Mesa, California, 91942
Velocity Clinical Research
Meridian, Idaho, 83642
Velocity Clinical Research
Mobile, Alabama, 36608
About this study
Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform Description This single-arm cohort, open-label, and multi-center study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including pulse rate (PR). It is hypothesized that the accuracy of the App is non-inferior to the accuracy of an FDA-cleared/approved vital sign monitoring device (reference device).
- Conditions
- Vital Sign Evaluation
- Being tested
- Informed Vital Core App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informed Vital Core AppDevice
All subjects assigned to a single arm, pulse rate measurement will be collected, calculated, and displayed on the web based application. A conventional ECG device will also be used to collect and display the heart rate at the same time. If additional consent is obtained subjects may provide blood pressure and SpO2 measurements for the web based application.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Rate Accuracy
The primary endpoint is a comparison to an FDA-cleared reference device to establish that PR measured with the IVC App is accurate.
Measured: 120 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start2 Jun 2023
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vital Sign EvaluationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mindset Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dan Lubelski, MD, Principal investigator, Mindset Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853380
- Sponsor's protocol ID
- IVC-400-006
- Status last verified
- Jun 2025
- First submitted
- 2 May 2023
- Last updated
- 3 Nov 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center Prospective Open Label Study of a Web-based Application for Pulse Rate in Adult Patients
- ClinicalTrials.gov ID
- NCT05853380
- Acronym / sponsor ID
- IVC-400-006
- Conditions
- Vital Sign Evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Mindset MedicalIndustry (pharma, biotech, devices)
- Study start
- 2 Jun 2023 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Posted 3 Nov 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the Accuracy of a Web-Based Application - Vital Sign Measurement Platform Description This single-arm cohort, open-label, and multi-center study is designed to evaluate the accuracy of a web-based application designed for measurements of vital signs including pulse rate (PR). It is hypothesized that the accuracy of the App is non-inferior to the accuracy of an FDA-cleared/approved vital sign monitoring device (reference device).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 22 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will recruit subjects from clinics and hospitals and the general public. Enrollment of 85 subjects with an age range of 22-85 years of age with a wide range of skin tone categorization per the Fitzpatrick Scale ranging from 1-6.
Key inclusion criteria (2 listed)
- Subjects 22 -85 years of age
- Subjects willing to sign the Informed Consent Form and comply with the protocol
Key exclusion criteria (7 listed)
- Subjects required to wear mask or bandage that obstructs forehead, cheeks, or chin
- Refusal to remove makeup , sunscreen, lotion, clothing, or items obstructing the face for the duration of measurement
- Presence of facial tattoos, large birthmarks, or other skin alterations (scars, hemangiomas, vitiligo) on upper cheeks (cheekbone) or forehead of the subject
- Condition that does not allow the subject to remain still for 60 seconds at a time
- Subjects with cardiac arrhythmia
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 |
|---|---|---|
| Informed Vital Core AppAll subjects assigned to a single arm, pulse rate measurement will be collected, calculated, and displayed on the web based application. A conventional ECG device will also be used to collect and display the heart rate at the same time. If additional consent is obtained subjects may provide blood pressure and SpO2 measurements for the web based application. | Device | – |
Primary outcome
Pulse Rate Accuracy
Time frame: 120 seconds
The primary endpoint is a comparison to an FDA-cleared reference device to establish that PR measured with the IVC App is accurate.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Dan Lubelski, MD principal investigator
Mindset Medical
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vital Sign Evaluation, run by Mindset Medical at 6 sites in United States.
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 2 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 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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?
Yes. Results are posted in the registry (first posted 3 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pulse Rate Accuracy (time frame: 120 seconds). 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 3 Nov 2025.