Comparison of Cuff-Less Wrist Wearable Blood Pressure Dev... | NCT04835857

Studies
Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices

NCT04835857

Sponsor

Dynocardia, Inc

Status

Recruiting

Last Update Posted

Sep 5, 2025Actual

Enrollment

91Estimated

Phase

Not provided

Conditions

Hypertension
Healthy

Interventions

ViTrack
Oscillometric BP Device
Auscultatory cuff

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jun 1, 2026Estimated

Completion Date

Nov 30, 2026Estimated

First Submitted Date

Apr 5, 2021

First Submission Date that Met QC Criteria

Apr 5, 2021

First Posted Date

Apr 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2025

Last Update Posted Date

Sep 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

91Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Experimental-Arm		For the same subject, ViTrack wrist cuff is applied on one of the wrist Standard Oscillometric cuff is applied to the brachial artery / wrist of the same arm Auscultatory cuff is applied to the brachial artery of the same arm	Device: ViTrack Device: Oscillometric BP Device Device: Auscultatory cuff

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ViTrack	Device	ViTrack is a continuous non-invasive wearable blood pressure cuff.	Experimental-Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparison of Diastolic Blood Pressure	3 sets readings compared across blood pressure (mmHg)	up to 30 minutes
Comparison of Systolic Blood Pressure	3 sets readings compared across blood pressure (mmHg)	up to 30 minutes

Secondary Outcomes

Measure	Description	Time Frame
Skin Irritation	Examining for local skin irritation	Up to 72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

adults

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohan Thanikachalam, MD	Contact	+1 (617) 639 - 5569		admin@dynocardia.care
Gokul Prasath Rajamanickam, MS	Contact			gokulpr@dynocardia.care

Overall Officials

Name	Affiliation	Role
Mohan Thanikachalam, MD	Dynocardia, Inc	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dynocardia Inc	Recruiting	Newton	Massachusetts	02459	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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.

Types

Study Protocol
Statistical Analysis Plan (SAP)

Time Frame

Data will become available following data analysis within 6 month of study completion and will remain available for up to 3 years.

Access Criteria

Data will be accessed via secure methods outlined in a data sharing agreement

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided