Avicena LVDP Validation Study in Healthy Volunteers | NCT05673174

Studies
Avicena LVDP Validation Study in Healthy Volunteers

NCT05673174

Sponsor

Ventric Health, LLC

Status

Completed

Last Update Posted

Jan 6, 2023Actual

Enrollment

321Actual

Phase

Not provided

Conditions

Healthy

Interventions

Non-Invasive Estimation of Left Ventricular Diastolic Pressure

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

Nov 2022

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

Jun 16, 2022Actual

Primary Completion Date

Aug 30, 2022Actual

Completion Date

Aug 30, 2022Actual

First Submitted Date

Dec 21, 2022

First Submission Date that Met QC Criteria

Dec 21, 2022

First Posted Date

Jan 6, 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

Dec 21, 2022

Last Update Posted Date

Jan 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

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 purpose of this study is to document the utility of the Vivio System in quantifying LVDP in healthy volunteers.

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

321Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-Invasive Estimation of Left Ventricular Diastolic Pressure	Diagnostic Test	Modified blood pressure cuff used to detect arterial waveforms used for the estimation of LVDP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To construct an algorithm from training data set to be used to estimate the ROC curve from the algorithm for a separate test data set.		3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult subjects >21 years of age.
No known significant health problems.
Willing and able to participate in all study evaluations.
Ability to understand and sign informed consent.

Exclusion Criteria:

Open skin lesions at the site of Vivio application / examination.
Inability to obtain brachial artery blood pressure.

Accepts Healthy Volunteers

Yes

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

Healthy Volunteers, no history of Heart Disease.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Avicena		Pasadena	California	91105	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided