VicorderCS NIBP Validation Study to Review The Ability to Capture Blood Pressure Measurements

NCT06560034 | Completed Results DMC

• 1 other identifier: Pro00080976
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

80 Beats Medical introduces the VicorderCS, the next generation of our Vicorder technology designed to manage hypertension and cardiovascular risks. This advanced diagnostic equipment offers non-invasive collection and computation of a plethora of cardiovascular markers. It is faster, easier to use, and more portable than its predecessor, with enhanced connectivity options for extended marker collection and analysis. These markers enable early diagnosis of cardiovascular disease, ensuring positive patient outcomes. With a strong foundation in numerous published clinical studies, the VicorderCS enhances data collection and analysis capabilities, empowering the research community in developing new drugs and therapeutics. This validation study is purposed to evaluate one of the physiological parameters that is measured by the VicorderCS system, which is Non-invasive Blood Pressure (NIBP) via the common oscillometric cuff-based method.

Conditions

Cardiovascular Diseases; Blood Pressure; Hypertension

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

  A mean difference was measured between the VicorderCS noninvasive blood pressure measurement method and the auscultation method using a Korotkoff sounds device with human observers' readings.

  1 Day

Study Arms (1)

Cross-Sectional Group

Blood pressure reading of one group of participants

Device: VicorderCS

Interventions

VicorderCS DEVICE

1. Vascular Sensor (VCS-VAS-1000) measurement device used with accessories (cuffs and tubes) connected to the device; 2. Data Station (VCS-DAT-1000) for data collection and analysis

Cross-Sectional Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy individuals meeting inclusion criteria in the Colorado area

You may qualify if:

• Any gender, in good general health
• Must be 18 years old or older, inclusive at enrollment
• Must be willing to provide blood pressure measurement
• Must be able to read, understand, and willingly sign an Informed Consent Form
• Must be able to read, speak and understand English
• Must be available to attend one study visit at: please specify exact location.

You may not qualify if:

• Excluding subjects with significantly irregular heart rhythm (e.g. Bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation) or are pregnant
• No active email address
• Non-English or Spanish- speaking
• Unable to read in English.

Sponsors & Collaborators

• 80 Beats Medical: lead

Study Sites (1)

Manos Health Study Site

Breckenridge, Colorado, 80424, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases

Results Point of Contact

• Title: Dr. Nitin Vaswani
• Organization: Manos Health

nitin@manoshealth.com

7577263449

Study Officials

• Nitin Vaswani, MD

  PI

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2024
• First Posted: August 19, 2024
• Study Start: August 15, 2024
• Primary Completion: July 10, 2025
• Study Completion: July 14, 2025
• Last Updated: June 29, 2026
• Results First Posted: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)