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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03128944
Other study ID # 12351
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2017
Est. completion date October 30, 2019

Study information

Verified date March 2020
Source Tufts University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

If the participant volunteers to participate in this study, after signing the informed consent, responses to background data - age, gender, height, weight, wrist circumference of dominant arm, history of high blood pressure, diabetes, high cholesterol and cardiovascular disease - will be collected; The BPI will be strapped to the right or left wrist making sure it is comfortable to the participant and the readings from the BPI will be recorded in a computer. The continuous BPI readings will be recorded for 2 minutes. Simultaneously, blood pressure readings will be obtained from a cuff-based, commercially available blood pressure measuring device placed in the same arm. The research team will take a minimum 3 and maximum 6 sets of readings. At the end of the BPI readings, we will place an ultrasound probe of the wrist at the level of the wrist to assess the size of the radial artery and depth of the artery from the skin.

Participant Timeline: The collection of the background data will take 5 to 10 mins. The placement of the BPI and cuff-blood pressure device and the data collection will take about 15 to 20 mins. The ultrasound image collection will 10 to 15 mins. Overall, the study procedures will be less than an hour.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 30, 2019
Est. primary completion date October 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Tufts University Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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