Blood PressureNCT03128944
Feasibility Assessment of the Blood Pressure Imager, a Continuous Blood Pressure Monitor
An observational study of Blood Pressure and Hypertension, run by Tufts University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hypertension
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 30 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Tests will be performed with any adult volunteer who is physically and mentally able to perform the experimental tasks.
Who cannot join
- We will restrict the experiments to adult volunteers who are physically and mentally able to consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of the Blood Pressure Imager
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.
Read the detailed 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.
- Conditions
- Blood Pressure, Hypertension
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start1 May 2017
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Thanikachalam, Tufts University
- Investigators
- Mohan Thanikachalam, Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128944
- Sponsor's protocol ID
- 12351
- Status last verified
- Mar 2020
- First submitted
- 21 Apr 2017
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of the Blood Pressure Imager
- ClinicalTrials.gov ID
- NCT03128944
- Acronym / sponsor ID
- 12351
- Conditions
- Blood Pressure, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 25 Apr 2017 (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.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Tests will be performed with any adult volunteer who is physically and mentally able to perform the experimental tasks.
Key exclusion criteria (1 listed)
- We will restrict the experiments to adult volunteers who are physically and mentally able to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of BPI measurements with reference blood pressure measurements
Time frame: 1 hour
Comparison of BPI measurements with reference blood pressure measurements with commercially available cuff-based blood pressure measuring device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Mohan Thanikachalam principal investigator
Tufts University
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 Blood Pressure and Hypertension, run by Tufts University 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of BPI measurements with reference blood pressure measurements (time frame: 1 hour). 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 27 Mar 2020.