NCT03128944

Brief Summary

The investigators are developing Blood Pressure Imager (BPI), which is a new technology that does not require cuffs or expensive equipment, and can be used by untrained individuals in underserved, low-resource environments at their own homes or regional care settings. Over the last one-year the investigators have developed the BPI prototype, which is ready for testing. BPI is a wrist device that includes a camera, color lights and soft membrane with a reflective coating. In this device feasibility study, the BPI will be placed over the radial artery at the wrist with the help of a wrist strap. The primary purpose of this feasibility study is to compare the BPI with a commercially available cuff-based blood pressure measuring devices.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 25, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

2.5 years

First QC Date

April 21, 2017

Last Update Submit

March 25, 2020

Conditions

Blood PressureHypertension

Outcome Measures

Primary Outcomes (1)

  • Comparison of BPI measurements with reference blood pressure measurements

    Comparison of BPI measurements with reference blood pressure measurements with commercially available cuff-based blood pressure measuring device

    1 hour

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study accepts adult (age of 18 years and above) volunteers with or without high blood pressure who are physically and mentally able to consent.

You may qualify if:

  • Tests will be performed with any adult volunteer who is physically and mentally able to perform the experimental tasks.

You may not qualify if:

  • We will restrict the experiments to adult volunteers who are physically and mentally able to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Mohan Thanikachalam

    Tufts University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant Professor

Study Record Dates

First Submitted

April 21, 2017

First Posted

April 25, 2017

Study Start

May 1, 2017

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)