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NCT03126994 · ClinicalTrials.gov registry record · NA

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

A NA study of Cardiovascular Risk Factor, sponsored by PhysioWave.

Completed
Registry status
NA
Development phase
160
Enrollment target
1
Study location

NCT03126994 is a NA study of Cardiovascular Risk Factor that has completed, run by PhysioWave. The registered enrollment target is 160 participants, below the 3,063-participant average among 31 other Cardiovascular Risk Factor trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT03126994, a NA study of Cardiovascular Risk Factor, has completed, sponsored by PhysioWave.

COMPLETED
Registry status
NA
Development phase
160 participants
Enrollment target
1
Study location

Study 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).

Conditions Studied

Interventions

  • DEVICE PhysioWave Cardiovascular Analyzer
  • DEVICE AtCor XCEL PWA & PWV
  • DEVICE Detecto SOLO

Study Locations (1)

California

  • Diablo Clinical Research - Walnut Creek

Trial Details

FieldValue
Enrollment Target 160 participants
Start Date 2017-04-11
Est. Completion 2017-05-19
Phase NA

Sponsor

PhysioWave

1 total trials

What the Registry Record Tells You About NCT03126994

The ClinicalTrials.gov registry entry for NCT03126994 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 160 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,063-participant average among 31 other Cardiovascular Risk Factor trials with a reported enrollment target (95% lower). The listed sponsor is PhysioWave, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Cardiovascular Risk Factor appearing as the primary indexed condition, and to 3 interventions - of which PhysioWave Cardiovascular Analyzer is the first listed.

NCT03126994 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT03126994 about?

NCT03126994 is a clinical study titled "Prospective, Single-Center, Non-Randomized Study of the PhysioWave™ Cardiovascular Analyzer". 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 demon...

What is the current status of trial NCT03126994?

This trial is currently completed. It is a NA study. The enrollment target is 160 participants. The study started on 2017-04-11. Estimated completion is 2017-05-19.

What conditions does trial NCT03126994 study?

This clinical trial studies the following conditions: Cardiovascular Risk Factor.

What interventions are being tested in trial NCT03126994?

The interventions under investigation include: PhysioWave Cardiovascular Analyzer (DEVICE), AtCor XCEL PWA & PWV (DEVICE), Detecto SOLO (DEVICE).

Who is sponsoring clinical trial NCT03126994?

This trial is sponsored by PhysioWave, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03126994 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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