mCVI Confirmatory Clinical Study: Algorithm Verification With Healthy Volunteers

February 10, 2023 updated by: Intelomed, Inc.

A Single-Center, Prospective Clinical Study to Demonstrate That mCVI(R) Accurately Captures Pulse Rate and Respiratory Rate in 20 Healthy Volunteers in Comparison to Traditional Measurements of the Nonin Lifesense Capnograph

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Cranberry Township, Pennsylvania, United States, 16066
        • InteloMed, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy Volunteers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intelomed, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

December 31, 2022

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ACTUAL)

December 31, 2022

Study Registration Dates

First Submitted

February 1, 2022

First Submitted That Met QC Criteria

February 1, 2022

First Posted (ACTUAL)

February 10, 2022

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • mCVI004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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