Blood PressureSelf_CalNCT02831777
CareTaker Self-Calibration Validation
An observational study of Blood Pressure, run by CareTaker Medical LLC.
Trial summary
The goal of the study is to test the capability of the CareTaker monitor to calibrate its continuous blood pressure readings independently. Currently the device requires another approved blood pressure monitor to provide a starting calibration. 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
- What is being tested?
- non-invasive blood pressure monitor
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- Mar 2016to May 2016
- 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: Subjects will be UVA patients/staff, > 18 years of age, who are able and willing to participate and have given verbal assent
Who may be able to join
- > 18 years of age, who are able and willing to participate and have given verbal assent
Who cannot join
- Unable to give verbal assent
- <18 years of age
- No or poor finger pulse, as determined through visual inspection for ischemic hands
About this study
The goal of the study is to test the capability of the CareTaker monitor to calibrate its continuous blood pressure readings independently. Currently the device requires another approved blood pressure monitor to provide a starting calibration.
The new control module enables the CareTaker to perform a pressure sweep of the internal pressure in the finger cuff. The resulting data is analyzed using a combination of pulse analysis/oscillometry approach.
Read the detailed description
The specific objective of this project was to demonstrate the CareTaker's ability to perform self-calibration to the same performance standard as its predicate device. That device demonstrated efficacy by showing substantial equivalence to the performance of classical sphygmomanometry using a Riva-Rocci/Korotkoff (RRK) measurement on the brachial artery, meeting a bias of at least 5 mmHg and a standard deviation of 8 mmHg across 3 paired readings from at least 85 patients, for a total of at least 255 paired readings.
The study was performed at the University of Virginia Medical Center in Charlottesville, Virginia. UVA's Institutional Review Board approved (#18686) and supervised the study for subjects who were University of Virginia hospital patients and staff > 18 years of age and who were able to give verbal consent.
- Conditions
- Blood Pressure
- Being tested
- non-invasive blood pressure monitor
- Keywords
- non-invasive blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-invasive blood pressure monitorDevice
Equivalence of CareTaker blood pressure to classical sphygmomanometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance comparison
Comparison with performance of classical sphygmomanometry using a Riva-Rocci/Korotkov (RRK) measurement on the brachial artery, meeting a bias of at least 5 mmHg and a standard deviation of 8 mmHg
Measured: 8 minutes for 3 paired readings
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016
- Study completionMay 2016
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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- CareTaker Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Responsible party
- Sponsor
- Investigators
- Martin C Baruch, PhD, Principal investigator, CareTaker Medical LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831777
- Sponsor's protocol ID
- SELF_CAL_001
- Acronym
- Self_Cal
- Status last verified
- Jul 2016
- First submitted
- 11 Jul 2016
- Last updated
- 13 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CareTaker Self-Calibration Validation
- ClinicalTrials.gov ID
- NCT02831777
- Acronym / sponsor ID
- Self_Cal / SELF_CAL_001
- Conditions
- Blood Pressure
- Keywords
- non-invasive blood pressure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- CareTaker Medical LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Virginia
- Study start
- Mar 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 Jul 2016 (estimated)
- 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 goal of the study is to test the capability of the CareTaker monitor to calibrate its continuous blood pressure readings independently. Currently the device requires another approved blood pressure monitor to provide a starting calibration.
The new control module enables the CareTaker to perform a pressure sweep of the internal pressure in the finger cuff. The resulting data is analyzed using a combination of pulse analysis/oscillometry approach.
Detailed description
The specific objective of this project was to demonstrate the CareTaker's ability to perform self-calibration to the same performance standard as its predicate device. That device demonstrated efficacy by showing substantial equivalence to the performance of classical sphygmomanometry using a Riva-Rocci/Korotkoff (RRK) measurement on the brachial artery, meeting a bias of at least 5 mmHg and a standard deviation of 8 mmHg across 3 paired readings from at least 85 patients, for a total of at least 255 paired readings.
The study was performed at the University of Virginia Medical Center in Charlottesville, Virginia. UVA's Institutional Review Board approved (#18686) and supervised the study for subjects who were University of Virginia hospital patients and staff > 18 years of age and who were able to give verbal consent.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be UVA patients/staff, > 18 years of age, who are able and willing to participate and have given verbal assent
Key inclusion criteria (1 listed)
- > 18 years of age, who are able and willing to participate and have given verbal assent
Key exclusion criteria (3 listed)
- Unable to give verbal assent
- <18 years of age
- No or poor finger pulse, as determined through visual inspection for ischemic hands
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 |
|---|---|---|
| non-invasive blood pressure monitorEquivalence of CareTaker blood pressure to classical sphygmomanometry | Device | – |
Primary outcome
Performance comparison
Time frame: 8 minutes for 3 paired readings
Comparison with performance of classical sphygmomanometry using a Riva-Rocci/Korotkov (RRK) measurement on the brachial artery, meeting a bias of at least 5 mmHg and a standard deviation of 8 mmHg
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 13 Jul 2016.
- Individual participant dataSharing planned: Undecided
Related trials for Blood Pressure
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
Recruiting
Blood Flow Restriction Training for Mechanically Ventilated Patients With ICU-Acquired Weakness
Intensive Care Unit Acquired Weakness
Active, not recruiting
Trial of Pistachio Consumption in Older Adults
Cognition, Cardiometabolic Risk Factors
RecruitingObservational study
Kidney Stiffness Measured by Ultrasound in Patients With High Blood Pressure and Healthy Volunteers
Arterial Hypertension, Chronic Kidney Disease, Primary Aldosteronism
Enrolling by invitationObservational study
Real-World Validation of A Huawei Smartwatch for Hypertension Risk Screening in Malaysia
Hypertension, Vascular Disease Risk
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.
Martin C Baruch, PhD principal investigator
CareTaker Medical LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Blood Pressure, run by CareTaker Medical LLC.
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 3 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 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Performance comparison (time frame: 8 minutes for 3 paired readings). 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 13 Jul 2016.