mCVI Confirmatory Clinical Study: Algorithm Verification... | NCT05233319

Studies
mCVI Confirmatory Clinical Study: Algorithm Verification With Healthy Volunteers

NCT05233319

Sponsor

Intelomed, Inc.

Status

Withdrawn

Last Update Posted

Feb 14, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Algorithm Verification

Interventions

There is no intervention

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

Feb 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of funding, project not being pursued

Expanded Access Info

Start Date

Dec 31, 2022Estimated

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Dec 31, 2022Actual

First Submitted Date

Feb 1, 2022

First Submission Date that Met QC Criteria

Feb 1, 2022

First Posted Date

Feb 10, 2022Actual

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

Feb 10, 2023

Last Update Posted Date

Feb 14, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This single center confirmatory clinical study is to verify the algorithm of mCVI® to accurately capture pulse rate and respiratory rate in 20 healthy subjects in comparison to traditional measurements of the Nonin Lifesense Capnograph. This is a non significant risk device.

Detailed Description

In this confirmatory clinical study the mCVI® device is a mobile application used to simply verify the algorithm when the mobile video reads a patients pulse rate and respiratory rate while spontaneously breathing. There is no facial recognition technology. There is no immediate feedback given to the research team to act upon or provide for further clinical care decisions. In real time, the mCVI® device will be compared to traditional measurements of the Nonin Lifesense Capnograph.

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

0Actual

Name	Type	Description	Arm Group Labels	Other Names
There is no intervention	Other	There is no intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pulse Rate Verification	To demonstrate that mCVI(R) accurately captures pulse rate comparison to Nonin Lifesense Capnograph	1 month
Respiration Rate Verification	To demonstrate that mCVI(R) accurately captures respiratory rate in comparison to Nonin Lifesense Capnograph	1 month

Secondary Outcomes

Measure	Description	Time Frame
Skin Tone Pulse Rate Verification	To demonstrate that mCVI(R) accurately captures pulse rate in healthy volunteers with a variety of skin tones	1 month
Skin Tone Respiration Rate Verification

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy adults between the ages of 21 - 70

Exclusion Criteria:

Medical conditions that could compromise a participant's ability to provide for all breathing samples, pedal the Cubii Pro elliptical, or follow instructions
Medications that could compromise a participant's ability to participate in the study
Documented medical history of respiratory or cardiovascular disease
Excessive facial hair, facial deformities, or obstructions (like glasses or face masks/shields) that could compromise the recording of pulse rate and respiratory rate of the mCVI®
Any face lotions or make up foundations that could compromise the recording of pulse rate and respiration rate of the mCVI®
Recent (≤ 1 month) surgical procedure of any kind
Current participation in another investigational clinical trial
Inability to provide informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy Volunteers

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
InteloMed, Inc.		Cranberry Township	Pennsylvania	16066	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