VL-3 Training Study

Status Completed

Clinical Trial Summary

The primary endpoints for this study are mean and standard deviation error measurements for the VLDBPM versus manual auscultation.

Clinical Trial Description

This is a prospective, controlled, single-arm clinical evaluation. Five hundred thirty-two (532) subjects are planned to be evaluated. Each subject's blood pressure will be measured using the VLDBPM and manual auscultation. Each subject will be observed while undergoing a series of blood pressure perturbation challenges. Means measurement differences from the test sensor and the reference auscultation measurements will be used to validate the accuracy of the VDBPM software system. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Total duration of subject participation will be 1 to 1.5 hours. Total duration of the study is expected to be 6 months. Following medical history and patient eligibility assessments, eligible patients will be offered participation in the study. Once subjects are consented/enrolled, measurements will be performed in accordance with Data Collection Procedure section below. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05356754
Study type	Interventional
Source	Riva Health
Contact
Status	Completed
Phase	N/A
Start date	July 13, 2020
Completion date	November 8, 2021

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