Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-01-25 @ 4:11 AM
Study NCT ID:
NCT03126994
Status:
COMPLETED
Last Update Posted:
2018-08-31
First Post:
2017-04-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective, Single-Center, Non-Randomized Study of the PhysioWave™ Cardiovascular Analyzer
Sponsor:
PhysioWave, Inc.
Organization:
Study Overview
Official Title:
Prospective, Single-Center, Non-Randomized Study of the PhysioWave™ Cardiovascular Analyzer
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: