Video Vitals and Biomarkers | NCT06136156

Studies
Video Vitals and Biomarkers

NCT06136156

Sponsor

Maiv Health Inc.

Status

Completed

Last Update Posted

Sep 29, 2025Actual

Enrollment

237Actual

Phase

Not provided

Conditions

Cardiometabolic Diseases

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 31, 2023Actual

Primary Completion Date

Sep 4, 2025Actual

Completion Date

Sep 4, 2025Actual

First Submitted Date

Oct 17, 2023

First Submission Date that Met QC Criteria

Nov 14, 2023

First Posted Date

Nov 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2025

Last Update Posted Date

Sep 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators are doing this research to study the ability of mobile devices to measure vital signs and biomarkers from video as compared to standard-of-care clinical office tools.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

237Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Heart rate in beats per minute		2 minutes
Blood pressure (systolic/diastolic) in millimeters of mercury (mmHg)		2 minutes
Respiration rate in breaths per minute		2 minutes
Oxygen saturation in SpO2 percentage		2 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be able to stay in a seated position for 30 minutes
Must be able to participate in a venous blood draw

Exclusion Criteria:

Condition that prevents prolonged seated position
Condition that restricts ability to provide venous blood sample

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adults greater than 18 years old may participate in this research study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sandro Luna, MD	Maiv Health Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
ARCpoint Labs of Cedar Park		Cedar Park	Texas	78613	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided