mCVI Confirmatory Clinical Study: Algorithm Verification

NCT04692064 | Completed

• 1 other identifier: mCVI002
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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 commercially-available Masimo pulse oximeter devices. This is a non significant risk device.

Conditions

Algorithm Verification

Outcome Measures

Primary Outcomes (2)

• Pulse Rate Verification

  To demonstrate that mCVI® accurately captures pulse rate in comparison to Masimo pulse oximeter devices

  2 months

• Respiration Rate Verification

  To demonstrate that mCVI® accurately captures respiratory rate in comparison to Masimo pulse oximeter devices.

  2 months

Secondary Outcomes (2)

• Skin Tone Pulse Rate Verification

  2 months

• Skin Tone Respiration Rate Verification

  2 months

Interventions

There is no intervention OTHER

There is no intervention

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy Volunteers

You may qualify if:

• Healthy adults between the ages of 21 - 70

You may not qualify if:

• 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

Sponsors & Collaborators

• Intelomed, Inc.: lead

Study Sites (1)

InteloMed, Inc.

Cranberry Township, Pennsylvania, 16066, United States

Location

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: December 31, 2020
• Study Start: February 3, 2021
• Primary Completion: February 5, 2021
• Study Completion: February 21, 2021
• Last Updated: February 23, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)