HypertensionNCT04835857
Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices
An observational study of Hypertension and Healthy, run by Dynocardia, Inc at 1 site in United States.
Trial summary
(1) To compare cuff-less wrist wearable radial artery blood pressure measurements utilizing ViTrack(developed by Dynocardia) to the cuff based commercially available blood pressure device, in healthy volunteers with normal or high blood pressure. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hypertension, Healthy
- What is being tested?
- ViTrack, Oscillometric BP Device and Auscultatory cuff
- Type of treatment
- Medical device
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 30 Nov 2026
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adults
Who may be able to join
- Health volunteers 18 years and above; equal numbers of males and females to address Sex As a Biological Variable (SABV); and in sinus rhythm.
- Agree to commit to participate in the current protocol.
- Provide written informed consent prior to any study procedures being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read).
Who cannot join
- Unable or unwilling to provide informed consent
- Any other condition that would increase the risk of participation in the study in the opinion of the site Investigator.
- A difference of >10 mm Hg in left versus right arm oscillometric systolic BP.
- Upper extremity arteriovenous hemodialysis shunt.
- Wrist distortion or pain from arthritis.
- Prior trauma or surgery at the radial artery monitoring site.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Gokul Prasath Rajamanickam, MS contact
United States1 site, 1 recruiting
- Recruiting
Dynocardia Inc
Newton, Massachusetts, 02459
Gokul Rajamanickam, gokulpr@dynocardia.care
About this study
Official title: Comparison of Cuff-Less Wrist Wearable to Cuff Based Commercial Available Blood Pressure Measuring Devices in Health Volunteers With Normal or High Blood Pressure
(1) To compare cuff-less wrist wearable radial artery blood pressure measurements utilizing ViTrack(developed by Dynocardia) to the cuff based commercially available blood pressure device, in healthy volunteers with normal or high blood pressure.
Read the detailed description
(1) The ViTrack is strapped over the radial artery at the wrist. The ViTrack blood pressure cuff will be utilized to obtain blood pressure(BP) readings in the volunteers with normal or high blood pressure. The readings from the ViTrack will be compared with the readings of a cuff-based, commercially available BP measuring device placed on the same arm.
- Conditions
- Hypertension, Healthy
- Being tested
- ViTrack, Oscillometric BP Device, Auscultatory cuff
- Keywords
- Blood Pressure, Cuff less, Wearable, BP
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViTrackDevice
ViTrack is a continuous non-invasive wearable blood pressure cuff.
Oscillometric BP DeviceDevice
Oscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings.
Auscultatory cuffDevice
The auscultatory method is the gold standard for clinical blood pressure measurement. A brachial cuff is mounted and a trained healthcare provider uses a sphygmomanometer and listens for the Korotkoff sounds using a stethoscope to measure blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| Experimental-Arm | For the same subject,
1. ViTrack wrist cuff is applied on one of the wrist
2. Standard Oscillometric cuff is applied to the brachial artery / wrist of the same arm
3. Auscultatory cuff is applied to the brachial artery of the same arm Receives: Device: ViTrack; Device: Oscillometric BP Device; Device: Auscultatory cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Diastolic Blood Pressure
3 sets readings compared across blood pressure (mmHg)
Measured: up to 30 minutes
Comparison of Systolic Blood Pressure
3 sets readings compared across blood pressure (mmHg)
Measured: up to 30 minutes
Secondary outcomes (1)
Skin Irritation
Examining for local skin irritation
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Jan 2021
- Primary completion1 Jun 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dynocardia, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mohan Thanikachalam, MD, Principal investigator, Dynocardia, Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835857
- Sponsor's protocol ID
- TBPI001
- Status last verified
- Aug 2025
- First submitted
- 5 Apr 2021
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Personal and medical information will stay confidential and secure and will be protected in accordance with current US law. All participants will be provided with a unique ID number. All participants' information such as participants' name and address as well as background information will be de-identified to protect subject confidentiality. Dynocardia or its designees will comply with all relevant data collection laws when collecting data for this study. Study databases will not include the participants name or address. Images will be captured by ViTrack under patient's ID in an electronic database. All other data will be de-identified for review purpose and transferred via a secure method.
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Cuff-Less Wrist Wearable to Cuff Based Commercial Available Blood Pressure Measuring Devices in Health Volunteers With Normal or High Blood Pressure
- ClinicalTrials.gov ID
- NCT04835857
- Acronym / sponsor ID
- TBPI001
- Conditions
- Hypertension, Healthy
- Keywords
- Blood Pressure, Cuff less, Wearable, BP
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Dynocardia, IncIndustry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 8 Apr 2021 (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.
(1) To compare cuff-less wrist wearable radial artery blood pressure measurements utilizing ViTrack(developed by Dynocardia) to the cuff based commercially available blood pressure device, in healthy volunteers with normal or high blood pressure.
Detailed description
(1) The ViTrack is strapped over the radial artery at the wrist. The ViTrack blood pressure cuff will be utilized to obtain blood pressure(BP) readings in the volunteers with normal or high blood pressure. The readings from the ViTrack will be compared with the readings of a cuff-based, commercially available BP measuring device placed on the same arm.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental-Arm | – | Device: ViTrack, Device: Oscillometric BP Device, Device: Auscultatory cuffFor the same subject, 1. ViTrack wrist cuff is applied on one of the wrist 2. Standard Oscillometric cuff is applied to the brachial artery / wrist of the same arm 3. Auscultatory cuff is applied to the brachial artery of the same arm |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adults
Key inclusion criteria (3 listed)
- Health volunteers 18 years and above; equal numbers of males and females to address Sex As a Biological Variable (SABV); and in sinus rhythm.
- Agree to commit to participate in the current protocol.
- Provide written informed consent prior to any study procedures being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read).
Key exclusion criteria (6 listed)
- Unable or unwilling to provide informed consent
- Any other condition that would increase the risk of participation in the study in the opinion of the site Investigator.
- A difference of >10 mm Hg in left versus right arm oscillometric systolic BP.
- Upper extremity arteriovenous hemodialysis shunt.
- Wrist distortion or pain from arthritis.
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 |
|---|---|---|
| ViTrackViTrack is a continuous non-invasive wearable blood pressure cuff. | Device | Experimental-Arm |
| Oscillometric BP DeviceOscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings. | Device | Experimental-Arm |
| Auscultatory cuffThe auscultatory method is the gold standard for clinical blood pressure measurement. A brachial cuff is mounted and a trained healthcare provider uses a sphygmomanometer and listens for the Korotkoff sounds using a stethoscope to measure blood pressure. | Device | Experimental-Arm |
Primary outcome
Comparison of Diastolic Blood Pressure
Time frame: up to 30 minutes
3 sets readings compared across blood pressure (mmHg)
Comparison of Systolic Blood Pressure
Time frame: up to 30 minutes
3 sets readings compared across blood pressure (mmHg)
1 secondary outcome
Skin Irritation
Time frame: Up to 72 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 5 Sep 2025.
- Individual participant dataSharing planned: Yes. Personal and medical information will stay confidential and secure and will be protected in accordance with current US law. All participants will be provided with a unique ID number. All participants' information such as participants' name and address as well as background information will be de-identified to protect subject confidentiality. Dynocardia or its designees will comply with all relevant data collection laws when collecting data for this study. Study databases will not include the participants name or address. Images will be captured by ViTrack under patient's ID in an electronic database. All other data will be de-identified for review purpose and transferred via a secure method.
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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.
Gokul Prasath Rajamanickam, MS contact
Mohan Thanikachalam, MD principal investigator
Dynocardia, Inc
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 Hypertension and Healthy, run by Dynocardia, Inc 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 Sep 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?
Contact Mohan Thanikachalam, MD (+1 (617) 639 - 5569, admin@dynocardia.care), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Diastolic Blood Pressure (time frame: up to 30 minutes). 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 Sep 2025.