Cardiovascular DiseasesNCT06560034
VicorderCS NIBP Validation Study to Review The Ability to Capture Blood Pressure Measurements
An observational study of Cardiovascular Diseases and Blood Pressure, run by 80 Beats Medical at 1 site in United States.
Trial summary
80 Beats Medical introduces the VicorderCS, the next generation of our Vicorder technology designed to manage hypertension and cardiovascular risks. This advanced diagnostic equipment offers non-invasive collection and computation of a plethora of cardiovascular markers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Blood Pressure, Hypertension
- What is being tested?
- VicorderCS
- Type of treatment
- Medical device
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2024to 14 Jul 2025
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Healthy individuals meeting inclusion criteria in the Colorado area
Who may be able to join
- Any gender, in good general health
- Must be 18 years old or older, inclusive at enrollment
- Must be willing to provide blood pressure measurement
- Must be able to read, understand, and willingly sign an Informed Consent Form
- Must be able to read, speak and understand English
- Must be available to attend one study visit at: please specify exact location.
Who cannot join
- Excluding subjects with significantly irregular heart rhythm (e.g. Bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation) or are pregnant
- No active email address
- Non-English or Spanish- speaking
- Unable to read in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Manos Health Study Site
Breckenridge, Colorado, 80424
About this study
Official title: VicorderCS NIBP Validation Study to Assess Its Ability to Capture Blood Pressure Measurements
80 Beats Medical introduces the VicorderCS, the next generation of our Vicorder technology designed to manage hypertension and cardiovascular risks. This advanced diagnostic equipment offers non-invasive collection and computation of a plethora of cardiovascular markers. It is faster, easier to use, and more portable than its predecessor, with enhanced connectivity options for extended marker collection and analysis. These markers enable early diagnosis of cardiovascular disease, ensuring positive patient outcomes. With a strong foundation in numerous published clinical studies, the VicorderCS enhances data collection and analysis capabilities, empowering the research community in developing new drugs and therapeutics. This validation study is purposed to evaluate one of the physiological parameters that is measured by the VicorderCS system, which is Non-invasive Blood Pressure (NIBP) via the common oscillometric cuff-based method.
Read the detailed description
The VicorderCS will enable medical personnel to conduct Blood Pressure measurement procedures for the evaluation of a participant's cardiovascular health.
Clinical Rationale This study will compare the accuracy of the 80 Beats Medical noninvasive blood pressure measurement using the VicorderCS device with that of human observers' readings using the auscultatory method, as required by the applicable ISO standard: Non-invasive sphygmomanometers part 2 - clinical investigation of intermittent automated measurement type1. The study will aim to enroll 120 participants for blood pressure readings using both the VicorderCS and auscultatory method using a calibrated aneroid sphygmomanometer.
Design Rationale The VicorderCS blood pressure study will be conducted using consenting participants in Summit County Colorado and designed to be compliant with the requirements within the applicable ISO standard1. Study data, including systolic and diastolic blood pressure readings, will be collected using both the VicorderCS and auscultatory method using a sphygmo-manometer.
Proposed Solution 80 Beats Medical has developed the VicorderCS, which is indicated for the non-invasive measurement of blood pressure to detect cardiovascular health risks.
Device Description
VicorderCS consists of the following components:
- Vascular Sensor (VCS-VAS-1000) measurement device used with accessories (cuffs and tubes) connected to the device;
- Data Station (VCS-DAT-1000) for data collection and analysis
Platform Data Privacy and Security The VicorderCS application follows industry best practices for data privacy and security, including compliance with applicable laws and regulations such as the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA). 80 Beats Medical has implemented technical and organizational measures to safeguard user data against unauthorized access, disclosure, alteration, or destruction, and regularly conducts security audits and risk assessments to identify and mitigate potential threats.
80 Beats Medical has established policies and procedures to ensure that user data is used only for its intended purpose and is not shared with unauthorized parties.
There are two data sets that will be recorded during this study. One is the pressure waveforms on all four limbs and the other is the Systolic and Diastolic blood pressure measurement on the left arm. All data on the vascular sensor will be deleted after the test is complete. However, the pressure waveforms will be uploaded to the data station before being deleted. This will be part of an internal data pool for use in perpetuity.
Users are provided with transparency and control over their data, including the ability to access, correct, and delete their information. Users can opt out of data collection and sharing, where applicable. Security and privacy of user data are critical to maintaining user trust, and 80 Beats Medical is committed to ensuring the application meets the highest standards for data privacy and security.
STUDY OBJECTIVES Primary Objective The objective of this study is to collect blood pressure readings using the VicorderCS device. We will subsequently conduct statistical analysis by comparing to the traditional sphygmomanometer method according to the ISO standard.
Secondary Objectives A secondary objective of this study is to collect raw waveform data on the opposite arm, and both ankles in order to optimize analysis capabilities in the future.
INVESTIGATIONAL PLAN General Schema of Study Design In this cross-sectional study, we will look at the systolic (Sys) and diastolic (Dia) blood pressure of 120 subjects (ages 18 years or older).
The primary hypothesis of this study is that the VicorderCS can detect and analyze blood pressure in an easy-to-use and portable device providing more complete diagnostics at the point of care.
Study Device 80 Beats Medical has developed the VicorderCSCS, which is indicated for the non-invasive measurement of blood pressure.
Indications for use The VicorderCS Device is indicated for adult patients needing a blood pressure reading.
- Conditions
- Cardiovascular Diseases, Blood Pressure, Hypertension
- Being tested
- VicorderCS
- Medical subject headings
- Cardiovascular Diseases, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VicorderCSDevice
- Vascular Sensor (VCS-VAS-1000) measurement device used with accessories (cuffs and tubes) connected to the device;
- Data Station (VCS-DAT-1000) for data collection and analysis
| Study group | Role | What they receive |
|---|---|---|
| Cross-Sectional Group | Blood pressure reading of one group of participants Receives: Device: VicorderCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
A mean difference was measured between the VicorderCS noninvasive blood pressure measurement method and the auscultation method using a Korotkoff sounds device with human observers' readings.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start15 Aug 2024
- Primary completion10 Jul 2025
- Study completion14 Jul 2025
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 Cardiovascular DiseasesStudies 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- 80 Beats Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nitin Vaswani, MD, Principal investigator, PI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560034
- Sponsor's protocol ID
- Pro00080976
- Status last verified
- Jun 2026
- First submitted
- 15 Aug 2024
- Last updated
- 29 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VicorderCS NIBP Validation Study to Assess Its Ability to Capture Blood Pressure Measurements
- ClinicalTrials.gov ID
- NCT06560034
- Acronym / sponsor ID
- Pro00080976
- Conditions
- Cardiovascular Diseases, Blood Pressure, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- 80 Beats MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 14 Jul 2025 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Posted 29 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
80 Beats Medical introduces the VicorderCS, the next generation of our Vicorder technology designed to manage hypertension and cardiovascular risks. This advanced diagnostic equipment offers non-invasive collection and computation of a plethora of cardiovascular markers. It is faster, easier to use, and more portable than its predecessor, with enhanced connectivity options for extended marker collection and analysis. These markers enable early diagnosis of cardiovascular disease, ensuring positive patient outcomes. With a strong foundation in numerous published clinical studies, the VicorderCS enhances data collection and analysis capabilities, empowering the research community in developing new drugs and therapeutics. This validation study is purposed to evaluate one of the physiological parameters that is measured by the VicorderCS system, which is Non-invasive Blood Pressure (NIBP) via the common oscillometric cuff-based method.
Detailed description
The VicorderCS will enable medical personnel to conduct Blood Pressure measurement procedures for the evaluation of a participant's cardiovascular health.
Clinical Rationale This study will compare the accuracy of the 80 Beats Medical noninvasive blood pressure measurement using the VicorderCS device with that of human observers' readings using the auscultatory method, as required by the applicable ISO standard: Non-invasive sphygmomanometers part 2 - clinical investigation of intermittent automated measurement type1. The study will aim to enroll 120 participants for blood pressure readings using both the VicorderCS and auscultatory method using a calibrated aneroid sphygmomanometer.
Design Rationale The VicorderCS blood pressure study will be conducted using consenting participants in Summit County Colorado and designed to be compliant with the requirements within the applicable ISO standard1. Study data, including systolic and diastolic blood pressure readings, will be collected using both the VicorderCS and auscultatory method using a sphygmo-manometer.
Proposed Solution 80 Beats Medical has developed the VicorderCS, which is indicated for the non-invasive measurement of blood pressure to detect cardiovascular health risks.
Device Description
VicorderCS consists of the following components:
- Vascular Sensor (VCS-VAS-1000) measurement device used with accessories (cuffs and tubes) connected to the device;
- Data Station (VCS-DAT-1000) for data collection and analysis
Platform Data Privacy and Security The VicorderCS application follows industry best practices for data privacy and security, including compliance with applicable laws and regulations such as the General Data Protection Regulation (GDPR) and the Health Insurance Portability and Accountability Act (HIPAA). 80 Beats Medical has implemented technical and organizational measures to safeguard user data against unauthorized access, disclosure, alteration, or destruction, and regularly conducts security audits and risk assessments to identify and mitigate potential threats.
80 Beats Medical has established policies and procedures to ensure that user data is used only for its intended purpose and is not shared with unauthorized parties.
There are two data sets that will be recorded during this study. One is the pressure waveforms on all four limbs and the other is the Systolic and Diastolic blood pressure measurement on the left arm. All data on the vascular sensor will be deleted after the test is complete. However, the pressure waveforms will be uploaded to the data station before being deleted. This will be part of an internal data pool for use in perpetuity.
Users are provided with transparency and control over their data, including the ability to access, correct, and delete their information. Users can opt out of data collection and sharing, where applicable. Security and privacy of user data are critical to maintaining user trust, and 80 Beats Medical is committed to ensuring the application meets the highest standards for data privacy and security.
STUDY OBJECTIVES Primary Objective The objective of this study is to collect blood pressure readings using the VicorderCS device. We will subsequently conduct statistical analysis by comparing to the traditional sphygmomanometer method according to the ISO standard.
Secondary Objectives A secondary objective of this study is to collect raw waveform data on the opposite arm, and both ankles in order to optimize analysis capabilities in the future.
INVESTIGATIONAL PLAN General Schema of Study Design In this cross-sectional study, we will look at the systolic (Sys) and diastolic (Dia) blood pressure of 120 subjects (ages 18 years or older).
The primary hypothesis of this study is that the VicorderCS can detect and analyze blood pressure in an easy-to-use and portable device providing more complete diagnostics at the point of care.
Study Device 80 Beats Medical has developed the VicorderCSCS, which is indicated for the non-invasive measurement of blood pressure.
Indications for use The VicorderCS Device is indicated for adult patients needing a blood pressure reading.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cross-Sectional Group | – | Device: VicorderCSBlood pressure reading of one group of participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Healthy individuals meeting inclusion criteria in the Colorado area
Key inclusion criteria (6 listed)
- Any gender, in good general health
- Must be 18 years old or older, inclusive at enrollment
- Must be willing to provide blood pressure measurement
- Must be able to read, understand, and willingly sign an Informed Consent Form
- Must be able to read, speak and understand English
Key exclusion criteria (4 listed)
- Excluding subjects with significantly irregular heart rhythm (e.g. Bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation) or are pregnant
- No active email address
- Non-English or Spanish- speaking
- Unable to read in English.
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 |
|---|---|---|
| VicorderCS1. Vascular Sensor (VCS-VAS-1000) measurement device used with accessories (cuffs and tubes) connected to the device; 2. Data Station (VCS-DAT-1000) for data collection and analysis | Device | Cross-Sectional Group |
Primary outcome
Blood Pressure
Time frame: 1 Day
A mean difference was measured between the VicorderCS noninvasive blood pressure measurement method and the auscultation method using a Korotkoff sounds device with human observers' readings.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- 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.
Nitin Vaswani, MD principal investigator
PI
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 Cardiovascular Diseases and Blood Pressure, run by 80 Beats Medical 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 6 inclusion and 4 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 29 Jun 2026. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2026). 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?
Blood Pressure (time frame: 1 Day). 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 29 Jun 2026.