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Cardiovascular Risk FactorNCT03126994

Prospective, Single-Center, Non-Randomized Study of the PhysioWave™ Cardiovascular Analyzer

A study testing PhysioWave Cardiovascular Analyzer, AtCor XCEL PWA & PWV and Detecto SOLO in people with Cardiovascular Risk Factor, run by PhysioWave, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, single-center, non-randomized validation study being conducted under a non-significant risk study design with the primary aim to evaluate PWV, PR, and BW accuracy in a sample of subjects representative of the US general adult population. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Cardiovascular Risk Factor
What is being tested?
PhysioWave Cardiovascular Analyzer, AtCor XCEL PWA & PWV and Detecto SOLO
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
1 siteUnited States
Study dates
11 Apr 2017to 19 May 2017
Phase
Interventional
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

Who may be able to join

  • Subjects >18 years old
  • Subject signs a written Informed Consent form to participate in the study, prior to any study procedures
  • Subgroup Inclusion Criteria
  • Subject has been taking ACE Inhibitors or Angiotensin Receptor Blockers for at least 30 days

Who cannot join

  • Known significant carotid or femoral artery stenosis
  • Non-palpable (non-detectable) arterial pulse at the sites of measurements
  • Pacemaker, defibrillator, or other cardiac stimulator
  • Erratic, accelerated or mechanically controlled irregular heart rhythm, or an arrhythmia
  • History of cardiac valve disorder or cardiac valve disease
  • History of venous disease, including venous insufficiency or deep vein thrombosis
Show all 18Show fewer
  • History of peripheral artery disease
  • Requirement for supplemental oxygen
  • Neuromuscular disorders that cause shaking or tremors (such as Parkinson's disease or Multiple Sclerosis), or other disease or condition affecting balance
  • Amputation or malformation of any limb or extremity (foot, leg, or arm) which would impede the placement of blood pressure cuffs or standing on the scale with two feet.
  • Known or suspected pregnancy
  • Inability to provide informed consent
  • Mental incompetence or a prisoner status
  • Current participation in a clinical trial of another investigational drug or device in which the study endpoint has not been met
  • BMI > 40
  • Subjects > 400 lbs
  • Subjects on strong vasoactive drugs, such as those used to control high blood pressure, for <30 days
  • Blood loss or blood donation of ˃ 550 mL within 30 days before study procedure

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Diablo Clinical Research

    Walnut Creek, California, 94598

Other trials in United States

About this study

This is a prospective, single-center, non-randomized validation study being conducted under a non-significant risk study design with the primary aim to evaluate PWV, PR, and BW accuracy in a sample of subjects representative of the US general adult population. The primary study objective is to demonstrate equivalency when measuring: Pulse Wave Velocity (PWV) and Pulse Rate (PR) between the PhysioWave Cardiovascular Analyzer (CA) and AtCor Medical SphygmoCor® XCEL PWA \& PWV (XCEL), and Body Weight (BW) between the CA and the Detecto Solo Digital Healthcare Scale (Detecto).

Being tested
PhysioWave Cardiovascular Analyzer, AtCor XCEL PWA & PWV, Detecto SOLO

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PhysioWave Cardiovascular AnalyzerDevice

    Measurement of Pulse Wave Velocity, Pulse Rate, Body Weight and BMI

  • AtCor XCEL PWA & PWVDevice

    Measurement of Pulse Wave Velocity and Pulse Rate

  • Detecto SOLODevice

    Measurement of Body Weight and BMI

Study groups in NCT03126994
Study groupRoleWhat they receive
PhysioWave Cardiovascular AnalyzerExperimentalThe Experimental Device is the PhysioWave Cardiovascular Analyzer, which will be used to measure Pulse Wave Velocity, Pulse Rate, Body Weight, and BMI. This will be compared to FDA-cleared devices to determine equivalence: AtCor XCEL PWA \& PWV to measure Pulse Wave Velocity and Pulse rate, and Detecto SOLO to measure Body Weight and BMI.
Receives: Device: PhysioWave Cardiovascular Analyzer; Device: AtCor XCEL PWA & PWV; Device: Detecto SOLO

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Objective: PWV Equivalence

    The first primary study objective is to demonstrate equivalency when measuring: pulse wave velocity (PWV) (in m/s) between the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA \& PWV.

    Measured: Day 1

  2. Pulse Rate Equivalence

    The second primary study objective is to demonstrate equivalency when measuring: pulse rate (in bpm) between the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA \& PWV.

    Measured: Day 1

  3. Body Weight Equivalence

    The third primary study objective is to demonstrate equivalency when measuring body weight (in kg) between the PhysioWave Cardiovascular Analyzer and the Detecto Solo.

    Measured: Day 1

Secondary outcomes (5)

  1. Secondary Objective: BMI Equivalence

    Demonstrate equivalency when measuring Body Mass Index (BMI) (in kg/m^2) between the PhysioWave Cardiovascular Analyzer and the Detecto Solo

    Measured: Day 1

  2. Secondary Objective: Precision Analysis, PWV

    Evaluate the precision of PWV measurements (in m/s) due to the sources of variation in measurements in the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA \& PWV. Sources of variation to be assessed include between-replicates, between-device, between-operator, and total (overall).

    Measured: Day 1 or Day 2

  3. Secondary Objective: Precision Analysis, Pulse Rate

    Evaluate the precision of pulse rate measurements (in bpm) due to the sources of variation in measurements in the PhysioWave Cardiovascular Analyzer and AtCor Medical SphygmoCor® XCEL PWA \& PWV. Sources of variation to be assessed include between-replicates, between-device, between-operator, and total (overall).

    Measured: Day 1 or Day 2

  4. Secondary Objective: Precision Analysis, Body Weight

    Evaluate the precision of body weight measurements (in kg) due to the sources of variation in measurements in the PhysioWave Cardiovascular Analyzer and the Detecto Solo. Sources of variation to be assessed include between-replicates, between-device, between-operator, and total (overall).

    Measured: Day 1 or Day 2

  5. Secondary Objective: Precision Analysis, BMI

    Evaluate the precision of BMI measurements (in kg/m^2) due to the sources of variation in measurements in the PhysioWave Cardiovascular Analyzer and the Detecto Solo. Sources of variation to be assessed include between-replicates, between-device, between-operator, and total (overall).

    Measured: Day 1 or Day 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2017
  2. Study start11 Apr 2017
  3. Primary completion19 May 2017
  4. Study completion19 May 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective validation study to evaluate PWV, PR, and BW accuracy in a sample of subjects representing the US general adult population.
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03126994
Sponsor's protocol ID
780-00033
Status last verified
Aug 2018
First submitted
10 Apr 2017
Last updated
31 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PhysioWave Cardiovascular Analyzer, AtCor XCEL PWA & PWV and Detecto SOLO in people with Cardiovascular Risk Factor, run by PhysioWave, Inc. 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 4 inclusion and 18 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 31 Aug 2018. 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?

Primary Objective: PWV Equivalence (time frame: Day 1). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03126994.

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 31 Aug 2018.

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