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VL-3 Training Study

Primary Purpose

Hypertension, Blood Pressure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

The Vital Labs Digital Blood Pressure Monitor

About this trial

This is an interventional other trial for Hypertension

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

University of California San Francisco
Diablo Clinical Research
University of Colorado Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

The Vital Labs Digital Blood Pressure Monitor

Arm Description

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.

Outcomes

Primary Outcome Measures

Mean difference between BP measures

Primary efficacy

Standard deviation of differences between BP measures

Primary Efficacy

Mean difference between BP measures

Primary efficacy

Standard deviation of differences between BP measures

Primary Efficacy

Secondary Outcome Measures

Full Information

NCT ID

NCT05356754

First Posted

April 22, 2022

Last Updated

April 26, 2022

Sponsor

Riva Health

Collaborators

Diablo Clinical Research, University of Colorado, Denver

1. Study Identification

Unique Protocol Identification Number

NCT05356754

Brief Title

VL-3 Training Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

July 13, 2020 (Actual)

Primary Completion Date

November 8, 2021 (Actual)

Study Completion Date

November 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riva Health

Collaborators

Diablo Clinical Research, University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Blood Pressure

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

343 (Actual)

8. Arms, Groups, and Interventions

Arm Title

The Vital Labs Digital Blood Pressure Monitor

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

The Vital Labs Digital Blood Pressure Monitor

Intervention Description

Primary Outcome Measure Information:

Title

Mean difference between BP measures

Description

Primary efficacy

Time Frame

Baseline

Title

Standard deviation of differences between BP measures

Description

Primary Efficacy

Time Frame

Baseline

Title

Mean difference between BP measures

Description

Primary efficacy

Time Frame

1.5 hours

Title

Standard deviation of differences between BP measures

Description

Primary Efficacy

Time Frame

1.5 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

University of California San Francisco

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Diablo Clinical Research

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94398

Country

United States

Facility Name

University of Colorado Hospital

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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