Feasibility StudyNCT05909605
Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor
An observational study of Feasibility Study and Medical Device, run by University of California, San Diego at 1 site in United States.
Trial summary
Blood pressure (BP) monitoring is essential for managing cardiovascular diseases. Arterial line (A-line), the clinical gold standard for BP monitoring, is too invasive for routine measurements. The sphygmomanometer, on the other hand, is non-invasive but captures only discrete values. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Feasibility Study, Medical Device
- What is being tested?
- sphygmomanometer and Arterial Line
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Oct 2020to 2 Dec 2023
- 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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants without any severe cardiac anomalies
Who may be able to join
- Are able to provide informed consent
- Have at least one arm
Who cannot join
- Active cardiac arrhythmias
- Any other unstable, active medical condition (i.e., cardiac arrythmia, uncontrolled diabetes, active heart failure, active liver failure)
- Currently pregnant (this will be confirmed with a urine pregnancy test in women of childbearing potential)
- Any large movements of the arms (e.g., chorea, dyskinesias, ballism), that in the investigators' opinion, would make it difficult to measure blood pressure using a standard blood pressure cuff
- Any active skin infection or wound on the arm that would interfere with the devices used to measure blood pressure
- Diagnosis of dementia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Measurements of Arterial Pulses and Blood Pressure Using a Novel Ultrasound Patch
Blood pressure (BP) monitoring is essential for managing cardiovascular diseases. Arterial line (A-line), the clinical gold standard for BP monitoring, is too invasive for routine measurements. The sphygmomanometer, on the other hand, is non-invasive but captures only discrete values. The recently introduced conformal ultrasound sensor offers non-invasive and continuous monitoring of BP, which can potentially improve the quality of patient care, but its accuracy has yet to be thoroughly validated. Here the investigators are working to validate the accuracy of a redesigned ultrasound sensor with enhanced reliability in BP measurements at-home and in clinics even under different interventions.
- Conditions
- Feasibility Study, Medical Device
- Being tested
- sphygmomanometer, Arterial Line
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sphygmomanometerDevice
Comparison to the ultrasound sensor
Arterial LineDevice
Comparison to the ultrasound sensor
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound blood pressure sensor | Not described Receives: Device: sphygmomanometer; Device: Arterial Line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device comparison to standard monitoring (Sphygmomanometer)
Clinical feasibility of the calibration accuracy of the non-invasive ultrasound blood pressure sensor in comparison to a sphygmomanometer on 10 participants.
Measured: 2 years
Device comparison to standard monitoring (A-line)
Clinical feasibility of the ultrasound blood pressure sensor for monitoring trend changes for continuous 12 hours of measurement in comparison to an arterial line in the Intensive Care Unit on 10 participants.
Measured: 2 years
Device comparison to standard monitoring (A-line)
Clinical feasibility of the ultrasound blood pressure sensor in comparison to an arterial line in the catheterization laboratory on 40 participants.
Measured: 3 years
Device comparison to standard monitoring (Sphygmomanometer)
Clinical feasibility of the device accuracy of the non-invasive ultrasound blood pressure sensor in comparison to a sphygmomanometer on 90 participants in consulting room on orthostatic hypotension participants.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start20 Oct 2020
- Primary completion1 Dec 2023
- Study completion2 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feasibility StudyStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheng Xu, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909605
- Sponsor's protocol ID
- 804119, 191474, 191527, 210799
- Status last verified
- Dec 2023
- First submitted
- 1 Jun 2023
- Last updated
- 5 Dec 2023
- Results posted
- 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 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Measurements of Arterial Pulses and Blood Pressure Using a Novel Ultrasound Patch
- ClinicalTrials.gov ID
- NCT05909605
- Acronym / sponsor ID
- 804119, 191474, 191527, 210799
- Conditions
- Feasibility Study, Medical Device
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 2 Dec 2023 (actual)
- First posted
- 18 Jun 2023 (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.
Blood pressure (BP) monitoring is essential for managing cardiovascular diseases. Arterial line (A-line), the clinical gold standard for BP monitoring, is too invasive for routine measurements. The sphygmomanometer, on the other hand, is non-invasive but captures only discrete values. The recently introduced conformal ultrasound sensor offers non-invasive and continuous monitoring of BP, which can potentially improve the quality of patient care, but its accuracy has yet to be thoroughly validated. Here the investigators are working to validate the accuracy of a redesigned ultrasound sensor with enhanced reliability in BP measurements at-home and in clinics even under different interventions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ultrasound blood pressure sensor | – | Device: sphygmomanometer, Device: Arterial Line |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants without any severe cardiac anomalies
Key inclusion criteria (2 listed)
- Are able to provide informed consent
- Have at least one arm
Key exclusion criteria (6 listed)
- Active cardiac arrhythmias
- Any other unstable, active medical condition (i.e., cardiac arrythmia, uncontrolled diabetes, active heart failure, active liver failure)
- Currently pregnant (this will be confirmed with a urine pregnancy test in women of childbearing potential)
- Any large movements of the arms (e.g., chorea, dyskinesias, ballism), that in the investigators' opinion, would make it difficult to measure blood pressure using a standard blood pressure cuff
- Any active skin infection or wound on the arm that would interfere with the devices used to measure blood pressure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sphygmomanometerComparison to the ultrasound sensor | Device | Ultrasound blood pressure sensor |
| Arterial LineComparison to the ultrasound sensor | Device | Ultrasound blood pressure sensor |
Primary outcome
Device comparison to standard monitoring (Sphygmomanometer)
Time frame: 2 years
Clinical feasibility of the calibration accuracy of the non-invasive ultrasound blood pressure sensor in comparison to a sphygmomanometer on 10 participants.
Device comparison to standard monitoring (A-line)
Time frame: 2 years
Clinical feasibility of the ultrasound blood pressure sensor for monitoring trend changes for continuous 12 hours of measurement in comparison to an arterial line in the Intensive Care Unit on 10 participants.
Device comparison to standard monitoring (A-line)
Time frame: 3 years
Clinical feasibility of the ultrasound blood pressure sensor in comparison to an arterial line in the catheterization laboratory on 40 participants.
Device comparison to standard monitoring (Sphygmomanometer)
Time frame: 4 years
Clinical feasibility of the device accuracy of the non-invasive ultrasound blood pressure sensor in comparison to a sphygmomanometer on 90 participants in consulting room on orthostatic hypotension participants.
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 5 Dec 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Feasibility Study and Medical Device, run by University of California, San Diego 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 2 inclusion and 6 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 5 Dec 2023. 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?
Device comparison to standard monitoring (Sphygmomanometer) (time frame: 2 years). The study lists 4 primary outcomes in all. 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 5 Dec 2023.