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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: Completed NA study of Cardiovascular Risk Factor, sponsored by PhysioWave.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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.
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
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2017-04-11 |
| Est. Completion | 2017-05-19 |
| Phase | NA |
What the finished NCT03126994 record still lists
NCT03126994 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 3,063-participant average among 31 other Cardiovascular Risk Factor trials with a reported enrollment target (95% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Cardiovascular Risk Factor
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03126994's enrollment target sits among peer trials
160 10th of 31 higher than 22 of 31 other Cardiovascular Risk Factor trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Risk Factor trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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