VL-3 Training Study

NCT05356754 | Completed FDA Device

• 1 other identifier: CP-0001
• Study Type: interventional
• Target: 343
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Hypertension; Blood Pressure

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

The Vital Labs Digital Blood Pressure Monitor

EXPERIMENTAL

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

Interventions

The Vital Labs Digital Blood Pressure Monitor DEVICE

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 Vital Labs Digital Blood Pressure Monitor

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• \. Are unable or unwilling to undergo all assessments associated with the study.
• \. Have a history of poor quality or difficulty performing auscultation measurements.
• \. 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.
• \. 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.
• \. Subjects who have known allergies to nitroglycerin (for subjects undergoing the nitroglycerin challenge).
• \. Subjects who have taken short acting nitroglycerin within 4 hours of the scheduled study. Such studies will be deferred for at least 4 hours.
• \. Subjects who have taken long acting nitroglycerin within 8 hours of the scheduled study. Such studies will be deferred for at least 8 hours.
• \. Subjects with pericardial tamponade, restrictive cardiomyopathy, or constrictive pericarditis, or cardiac output is dependent upon venous return

Sponsors & Collaborators

• Riva Health: lead
• Diablo Clinical Research: collaborator
• University of Colorado, Denver: collaborator

Study Sites (3)

University of California San Francisco

San Francisco, California, 94143, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94398, United States

Location

University of Colorado Hospital

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2022
• First Posted: May 2, 2022
• Study Start: July 13, 2020
• Primary Completion: November 8, 2021
• Study Completion: November 8, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)