Validation of a new device for measuring blood pressure
VicorderCS NIBP Validation Study to Assess Its Ability to Capture Blood Pressure Measurements
80 Beats Medical · NCT06560034
This study is testing a new device for measuring blood pressure to see if it works as well as the traditional method in helping people with their heart health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | 80 Beats Medical (industry) |
| Locations | 1 site (Breckenridge, Colorado) |
| Trial ID | NCT06560034 on ClinicalTrials.gov |
What this trial studies
The VicorderCS NIBP Validation Study aims to evaluate the accuracy of the VicorderCS device in measuring non-invasive blood pressure compared to traditional methods. This observational study will enroll 120 participants who will undergo blood pressure readings using both the VicorderCS and the auscultatory method with a calibrated sphygmomanometer. The study is designed to comply with ISO standards and will take place in Summit County, Colorado. The goal is to enhance the capabilities of cardiovascular health assessments and improve early diagnosis of related diseases.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older in good general health who can provide informed consent and understand English.
Not a fit: Patients with significantly irregular heart rhythms or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and efficient blood pressure monitoring, improving patient outcomes in cardiovascular health.
How similar studies have performed: Previous studies have shown success with similar non-invasive blood pressure measurement technologies, indicating potential for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Breckenridge, Colorado
- Manos Health Study Site — Breckenridge, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Nitin Vaswani, MD — PI
- Study coordinator: Nitin Vaswani, MD
- Email: nitin@manoshealth.com
- Phone: 2025396941
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiovascular Diseases, Blood Pressure, Hypertension