Algorithm VerificationNCT04692064
mCVI Confirmatory Clinical Study: Algorithm Verification
An observational study of Algorithm Verification, run by Intelomed, Inc. at 1 site in United States.
Trial 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 commercially-available Masimo pulse oximeter devices. This is a non significant risk device. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Algorithm Verification
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2021to 21 Feb 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy Volunteers
Who may be able to join
- Healthy adults between the ages of 21 - 70
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
InteloMed, Inc.
Cranberry Township, Pennsylvania, 16066
About this study
Official title: 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.
Read the 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.
- Conditions
- Algorithm Verification
- Being tested
- There is no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
There is no interventionOther
There is no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Rate Verification
To demonstrate that mCVI® accurately captures pulse rate in comparison to Masimo pulse oximeter devices
Measured: 2 months
Respiration Rate Verification
To demonstrate that mCVI® accurately captures respiratory rate in comparison to Masimo pulse oximeter devices.
Measured: 2 months
Secondary outcomes (2)
Skin Tone Pulse Rate Verification
To demonstrate that mCVI® accurately captures pulse rate in healthy volunteers with a variety of skin tones.
Measured: 2 months
Skin Tone Respiration Rate Verification
To demonstrate that mCVI® accurately captures respiration rates in healthy volunteers with a variety of skin tones.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start3 Feb 2021
- Primary completion5 Feb 2021
- Study completion21 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Algorithm VerificationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Intelomed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04692064
- Sponsor's protocol ID
- mCVI002
- Status last verified
- Feb 2021
- First submitted
- 29 Dec 2020
- Last updated
- 23 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04692064
- Acronym / sponsor ID
- mCVI002
- Conditions
- Algorithm Verification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Intelomed, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Feb 2021 (actual)
- Primary completion
- 5 Feb 2021 (actual)
- Study completion
- 21 Feb 2021 (actual)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Family based
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy Volunteers
Key inclusion criteria (1 listed)
- Healthy adults between the ages of 21 - 70
Key exclusion criteria (10 listed)
- 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®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| There is no interventionThere is no intervention | Other | – |
Primary outcome
Pulse Rate Verification
Time frame: 2 months
To demonstrate that mCVI® accurately captures pulse rate in comparison to Masimo pulse oximeter devices
Respiration Rate Verification
Time frame: 2 months
To demonstrate that mCVI® accurately captures respiratory rate in comparison to Masimo pulse oximeter devices.
2 secondary outcomes
Skin Tone Pulse Rate Verification
Time frame: 2 months
Skin Tone Respiration Rate Verification
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Algorithm Verification, run by Intelomed, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Rate Verification (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2021.