Prospective, Single-Center, Non-Randomized Study of the PhysioWave™ Cardiovascular Analyzer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- PhysioWave, Inc.
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Primary Objective: PWV Equivalence
Study Overview
Brief 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. 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).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
- •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
Arms & Interventions
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.
Intervention: PhysioWave Cardiovascular Analyzer (Device)
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.
Intervention: AtCor XCEL PWA & PWV (Device)
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.
Intervention: Detecto SOLO (Device)
Outcomes
Primary Outcomes
Primary Objective: PWV Equivalence
Time Frame: Day 1
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.
Pulse Rate Equivalence
Time Frame: Day 1
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.
Body Weight Equivalence
Time Frame: Day 1
The third primary study objective is to demonstrate equivalency when measuring body weight (in kg) between the PhysioWave Cardiovascular Analyzer and the Detecto Solo.
Secondary Outcomes
- Secondary Objective: Precision Analysis, Pulse Rate(Day 1 or Day 2)
- Secondary Objective: BMI Equivalence(Day 1)
- Secondary Objective: Precision Analysis, PWV(Day 1 or Day 2)
- Secondary Objective: Precision Analysis, Body Weight(Day 1 or Day 2)
- Secondary Objective: Precision Analysis, BMI(Day 1 or Day 2)