Blood PressureNCT06887465
Non-invasive and Continuous Blood Pressure Monitoring
An observational study of Blood Pressure, run by Vena Vitals at 1 site in United States.
Trial summary
The goal of this observational study is to evaluate the accuracy and reliability of the VeriTrack non-invasive blood pressure monitor compared to radial arterial catheterization in adult surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Pressure
- What is being tested?
- Non-invasive Blood Pressure Monitor
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2025to Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing surgery who have an arterial line and are in supine position
Who may be able to join
- Patients whose blood pressure will be monitored using an arterial line during their procedure
- Patients who have a palpable dorsalis pedis pulse
Who cannot join
- Patients who have non-palpable dorsalis pedis pulses
- Patients whose limbs are inaccessible for placement of Vena Vitals Wearable
- Patients with known allergy to adhesives and/or silicone
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Jennifer Lessin, RN, 215-955-6161, Jennifer.Lessin@jefferson.edu
Jeffrey Joseph, DO
About this study
Official title: Comparison of Non-Invasive Wearable Sensors to Radial Arterial Catheterization on Human Subjects
The goal of this observational study is to evaluate the accuracy and reliability of the VeriTrack non-invasive blood pressure monitor compared to radial arterial catheterization in adult surgical patients.
The main question it aims to answer is:
How well does VeriTrack measure continuous blood pressure compared to an arterial catheter?
Researchers will compare VeriTrack readings to arterial line measurements to determine if the VeriTrack provides comparable accuracy and clinical utility.
Participants will wear the VeriTrack device during surgery and have a radial arterial catheter placed as part of standard care.
- Conditions
- Blood Pressure
- Being tested
- Non-invasive Blood Pressure Monitor
- Keywords
- Blood pressure monitoring, Non-invasive Blood Pressure Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive Blood Pressure MonitorDevice
Application of the VeriTrack non-invasive blood pressure monitor
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the VeriTrack device in continuous blood pressure monitoring
Systolic, diastolic, and mean arterial pressure (MAP) values will be compared between the VeriTrack and the arterial line using a Bland-Altman analysis.
Measured: 1-24 hours
Secondary outcomes (1)
Blood Pressure Change Accuracy
Changes in sys, dia, and MAP measured by VeriTrack will be evaluated and compared to the changes measured by the arterial line
Measured: 1-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study startJun 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vena Vitals
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Thomas Jefferson University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887465
- Sponsor's protocol ID
- VVAL0001
- Status last verified
- Mar 2025
- First submitted
- 13 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Non-Invasive Wearable Sensors to Radial Arterial Catheterization on Human Subjects
- ClinicalTrials.gov ID
- NCT06887465
- Acronym / sponsor ID
- VVAL0001
- Conditions
- Blood Pressure
- Keywords
- Blood pressure monitoring, Non-invasive Blood Pressure Monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Vena VitalsIndustry (pharma, biotech, devices)
- Collaborators
- Thomas Jefferson University
- Study start
- Jun 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Mar 2025 (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.
The goal of this observational study is to evaluate the accuracy and reliability of the VeriTrack non-invasive blood pressure monitor compared to radial arterial catheterization in adult surgical patients.
The main question it aims to answer is:
How well does VeriTrack measure continuous blood pressure compared to an arterial catheter?
Researchers will compare VeriTrack readings to arterial line measurements to determine if the VeriTrack provides comparable accuracy and clinical utility.
Participants will wear the VeriTrack device during surgery and have a radial arterial catheter placed as part of standard care.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing surgery who have an arterial line and are in supine position
Key inclusion criteria (2 listed)
- Patients whose blood pressure will be monitored using an arterial line during their procedure
- Patients who have a palpable dorsalis pedis pulse
Key exclusion criteria (3 listed)
- Patients who have non-palpable dorsalis pedis pulses
- Patients whose limbs are inaccessible for placement of Vena Vitals Wearable
- Patients with known allergy to adhesives and/or silicone
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 |
|---|---|---|
| Non-invasive Blood Pressure MonitorApplication of the VeriTrack non-invasive blood pressure monitor | Device | – |
Primary outcome
Accuracy of the VeriTrack device in continuous blood pressure monitoring
Time frame: 1-24 hours
Systolic, diastolic, and mean arterial pressure (MAP) values will be compared between the VeriTrack and the arterial line using a Bland-Altman analysis.
1 secondary outcome
Blood Pressure Change Accuracy
Time frame: 1-24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by Vena Vitals at 1 site 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 3 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: opening soon, as of the sponsor's last update on 3 Apr 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the VeriTrack device in continuous blood pressure monitoring (time frame: 1-24 hours). 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 Apr 2025.