NCT04296227 (NIBP) is a NA clinical trial of The Vital Detect blood pressure monitor in Blood Pressure, sponsored by Vital USA, Inc..

Who is sponsoring NCT04296227?

NCT04296227 is sponsored by Vital USA, Inc..

What drugs are being tested in NCT04296227?

Interventions in NCT04296227: The Vital Detect blood pressure monitor.

What condition does NCT04296227 study?

NCT04296227 studies Blood Pressure.

Is NCT04296227 still recruiting?

NCT04296227 is currently completed. Last updated 13 May 2020.

Are results published for NCT04296227?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-05-13 · How we verify

NCT04296227: NIBP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Comparison of Non-Invasive Blood Pressure Methods

Completed NA Results posted Last updated 13 May 2020

What this trial tests

NA trial testing The Vital Detect blood pressure monitor in Blood Pressure in 85 participants. Completed in 3 March 2020.

Timeline

4 February 2020

Primary endpoint
3 March 2020

3 March 2020

Quick facts

Lead sponsor	Vital USA, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	85
Start date	4 February 2020
Primary completion	3 March 2020
Estimated completion	3 March 2020
Sites	1 location across United States

Drugs / interventions tested

The Vital Detect blood pressure monitor

Conditions studied

Blood Pressure — all drugs for Blood Pressure →

Sponsor

Vital USA, Inc.

Who can join

18 and older, any sex, with Blood Pressure. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Validate Non-invasive Blood Pressure Measurement Accuracy for the Vital Detect Blood Pressure Monitor. Primary · 1 Hour

The primary objective of this study is to provide a validation for non-invasive blood pressure measurement accuracy for the Vital Detect blood pressure monitor when compared to the Reference Sphygmomanometer. Data taken was based on dual observers (Criterion 1(C1), Criterion 2 (C2) for both Systolic and Diastolic determinations. Since the same arm sequential method was used, data for a given subject were averaged to create the reference blood pressure determination against the acceptance criteria. The device under test (DUT) passed or failed the determination based on the mean error and standa

Systolic Pressure C1

Group	Value	95% CI
ISO 81060-2:2018.	4.40	± 10.97

Systolic Pressure C2

Group	Value	95% CI
ISO 81060-2:2018.	4.40	± 9.24

Diastolic Pressure C1

Group	Value	95% CI
ISO 81060-2:2018.	3.26	± 7.21

Diastolic Pressure C2

Group	Value	95% CI
ISO 81060-2:2018.	3.26	± 6.72

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Other Vital USA, Inc. trials

Trials by the same sponsor.

NCT04292639 — Vital USA Respiratory Rate Validation In Adults · NA · completed
NCT04285411 — Vital USA SpO2 Accuracy Comparison to Arterial Blood CO-Oximetry · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04296227 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Vital USA, Inc.
Last refreshed: 13 May 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04296227.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing