NCT05233319

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
11 months until next milestone

Study Start

First participant enrolled

December 31, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 14, 2023

Status Verified

February 1, 2023

Enrollment Period

Same day

First QC Date

February 1, 2022

Last Update Submit

February 10, 2023

Conditions

Algorithm Verification

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • Skin Tone Pulse Rate Verification

    1 month

  • Skin Tone Respiration Rate Verification

    1 month

Interventions

There is no interventionOTHER

There is no intervention

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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®
  • Recent (≤ 1 month) surgical procedure of any kind
  • Current participation in another investigational clinical trial
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InteloMed, Inc.

Cranberry Township, Pennsylvania, 16066, United States

Location
0

Study Design

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

Study Record Dates

First Submitted

February 1, 2022

First Posted

February 10, 2022

Study Start

December 31, 2022

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 14, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)