Hypertension Clinical Trial
Official title:
Development of the Blood Pressure Imager
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 |
Verified date | March 2020 |
Source | Tufts University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
United States | Tufts University | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tufts University |
United States,
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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