Prospective, Single-Center, Non-Randomized Study of the PhysioWave™ Cardiovascular Analyzer
NCT ID: NCT03126994
Last Updated: 2018-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2017-04-11
2017-05-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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PhysioWave Cardiovascular Analyzer
The 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.
PhysioWave Cardiovascular Analyzer
Measurement of Pulse Wave Velocity, Pulse Rate, Body Weight and BMI
AtCor XCEL PWA & PWV
Measurement of Pulse Wave Velocity and Pulse Rate
Detecto SOLO
Measurement of Body Weight and BMI
Interventions
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PhysioWave Cardiovascular Analyzer
Measurement of Pulse Wave Velocity, Pulse Rate, Body Weight and BMI
AtCor XCEL PWA & PWV
Measurement of Pulse Wave Velocity and Pulse Rate
Detecto SOLO
Measurement of Body Weight and BMI
Eligibility Criteria
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Inclusion Criteria
* Subject signs a written Informed Consent form to participate in the study, prior to any study procedures
* Subject has been taking ACE Inhibitors or Angiotensin Receptor Blockers for at least 30 days
Exclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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PhysioWave, Inc.
INDUSTRY
Responsible Party
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Locations
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Diablo Clinical Research
Walnut Creek, California, United States
Countries
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Other Identifiers
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780-00033
Identifier Type: -
Identifier Source: org_study_id
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