CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 85 enrolled
Drug / intervention
The Vital Detect blood pressure monitordevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04296227
NCT04296227N/ACompleted
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Multiparameter Monitor Non-Invasive Blood Pressure Validation Study

Vital USA, Inc.·interventional·Posted Mar 5, 2020·Updated May 13, 2020

In Brief

A clinical study evaluating The Vital Detect blood pressure monitor for Blood Pressure. Completed, enrolled 85 participants across 1 site.

Detailed Summary

The primary objective of the study is to demonstrate the accuracy in healthy adults with Vital USA Device by comparison to a non-invasive (auscultatory) reference sphygmomanometer. The procedure, data collection methods and data analysis that are outlined in the protocol follow the standard: International Standards Organization (ISO) 81060-2:2018 Non-invasive Sphygmomanometers - Part 2: Clinical validation of automated measurement type.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBlood Pressure
CountriesUnited States
CollaboratorsClinimark, LLC

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedMar 5, 2020
Enrollment StartFeb 4, 2020
Primary CompletionMar 3, 2020
TodayJul 2, 2026
Enrollment to primary: 29 daysPosted 6.3 years ago

Interventions

The Vital Detect blood pressure monitordevice

The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor.