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VL-3 Training Study

NCT05356754 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2022-05-02

No results posted yet for this study

Summary

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

Conditions

Interventions

DEVICE

The Vital Labs Digital Blood Pressure Monitor

The Vital Labs Digital Blood Pressure monitor is a software-as-a-medical device (SaMD) that is capable of determining blood pressure, after calibration, using waveform changes observed in photoplethysmogram signals.

Sponsors & Collaborators

  • Diablo Clinical Research

    collaborator UNKNOWN

  • University of Colorado, Denver

    collaborator OTHER

  • Riva Health

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-07-13
Primary Completion
2021-11-08
Completion
2021-11-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05356754 on ClinicalTrials.gov