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Compensatory Reserve Index (CRI) for Management of COVID-19

NCT04457817 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 16

Last updated 2021-11-11

No results posted yet for this study

Summary

The FDA has approved the CipherOx CRI T1 Tablet for use in subjects aged 19-36, and that this study aims to evaluate the device in subjects aged outside of this range and is being used off label.

The FDA determined the Cipher OX CRI T1 Tablet to be a class II device in 2016, and additional research has been done since the FDA determination to further support the use of the device outside of its current labeling.

Conditions

Interventions

DEVICE

CRI

Monitoring via CRI

Sponsors & Collaborators

  • Children's Hospital Colorado

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Steven L Moulton, MD · Children's Hospital Colorado

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-01
Primary Completion
2021-04-08
Completion
2021-04-08
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04457817 on ClinicalTrials.gov