- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04692064
mCVI Confirmatory Clinical Study: Algorithm Verification
February 22, 2021 updated by: Intelomed, Inc.
A Single-Center, Prospective Clinical Study to Demonstrate That mCVI® Accurately Captures Pulse Rate and Respiratory Rate in 20 Healthy Volunteers in Comparison to Commercially- Available Masimo Pulse Oximeter Devices
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 commercially-available Masimo pulse oximeter devices.
This is a non significant risk device.
Study Overview
Status
Completed
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 two commercially available Masimo pulse oximeter devices in a single visit.
Study Type
Observational
Enrollment (Actual)
20
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
-
-
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®
- Missing digits or fingers on one or more hand that would prevent proper recording of Masimo pulse oximeter devices
- Participants wearing nail polish, acrylic nails, or rings on the ring finger of either hand that would prevent the proper use of Masimo pulse oximeter device
- 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: 2 months
|
To demonstrate that mCVI® accurately captures pulse rate in comparison to Masimo pulse oximeter devices
|
2 months
|
Respiration Rate Verification
Time Frame: 2 months
|
To demonstrate that mCVI® accurately captures respiratory rate in comparison to Masimo pulse oximeter devices.
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Skin Tone Pulse Rate Verification
Time Frame: 2 months
|
To demonstrate that mCVI® accurately captures pulse rate in healthy volunteers with a variety of skin tones.
|
2 months
|
Skin Tone Respiration Rate Verification
Time Frame: 2 months
|
To demonstrate that mCVI® accurately captures respiration rates in healthy volunteers with a variety of skin tones.
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Actual)
February 3, 2021
Primary Completion (Actual)
February 5, 2021
Study Completion (Actual)
February 21, 2021
Study Registration Dates
First Submitted
December 29, 2020
First Submitted That Met QC Criteria
December 29, 2020
First Posted (Actual)
December 31, 2020
Study Record Updates
Last Update Posted (Actual)
February 23, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
February 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- mCVI002
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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