VL-3 Training Study

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

Detailed Description
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This is a prospective, controlled, single-arm clinical evaluation. Five hundred thirty-two (532) subjects are planned to be evaluated. Each subject's blood pressure will be measured using the VLDBPM and manual auscultation. Each subject will be observed while undergoing a series of blood pressure perturbation challenges. Means measurement differences from the test sensor and the reference auscultation measurements will be used to validate the accuracy of the VDBPM software system. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Total duration of subject participation will be 1 to 1.5 hours. Total duration of the study is expected to be 6 months. Following medical history and patient eligibility assessments, eligible patients will be offered participation in the study. Once subjects are consented/enrolled, measurements will be performed in accordance with Data Collection Procedure section below.

Official Title
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PROSPECTIVE STUDY EVALUATING THE VITAL LABS DIGITAL BLOOD PRESSURE MONITOR (VLDBPM)

Conditions
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Hypertension, Blood Pressure

Intervention / Treatment
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* Device: The Vital Labs Digital Blood Pressure Monitor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female ≥18 and ≤ 85 years of age at the Baseline Visit. Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study. A minimum of 30% of the data will be derived from male subjects; and a minimum of 30% of the data will be derived from female subjects. A minimum of 50 participants will have dark skin types, as defined by the Fitzpatrick Skin Type classification V or VI. Also, at least 10 participants should exhibit finger calluses, found typically on individuals who play stringed instruments frequently. Exclusion Criteria: 1. Pregnant and/or breastfeeding. 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data. 3. Are unable or unwilling to undergo all assessments associated with the study. 4. Have a history of poor quality or difficulty performing auscultation measurements. 5. Subjects shall be excluded if the Korotkoff sound [fifth phase (K5)] is not audible 6. Subjects with vascular implants in the arm of measurement, such as those used for dialysis 7. Subject suffering from a medical condition prohibiting blood flow occlusion in either arms. 8. Pre-existing conditions that may interfere with the accuracy or interpretation of auscultatory readings, such as aortic coarctation, arterial-venous malformation, occlusive arterial disease, or the presence of an antecubital bruit. 9. Subjects who have known allergies to nitroglycerin (for subjects undergoing the nitroglycerin challenge). 10. Subjects who have taken short acting nitroglycerin within 4 hours of the scheduled study. Such studies will be deferred for at least 4 hours. 11. Subjects who have taken long acting nitroglycerin within 8 hours of the scheduled study. Such studies will be deferred for at least 8 hours. 12. Subjects with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, or cardiac output is dependent upon venous return

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: The Vital Labs Digital Blood Pressure Monitor<br>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. The VLDBPM captures PPG signals using the existing camera systems on iPhones. These PPG signals are normalized and processed to determine markers of blood pressure change. These markers, when transformed using a predetermined model, are capable of determining blood pressure changes from a known (calibration) set-point. | Device: The Vital Labs Digital Blood Pressure Monitor<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference between BP measures | Primary efficacy | Baseline | 
| Standard deviation of differences between BP measures | Primary Efficacy | Baseline | 
| Mean difference between BP measures | Primary efficacy | 1.5 hours | 
| Standard deviation of differences between BP measures | Primary Efficacy | 1.5 hours |