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Clinical Validation Study for Noninvasive Cardiopulmonary Management Device

NCT04865640 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2024-08-06

Study results available
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Summary

The ADI At-Home CPM (Cardiopulmonary Management) System is a non-invasive device that measures and trends a variety of biological parameters.

This study will be conducted as a prospective non-randomized study with two study arms/cohorts - one of healthy adult patients, one of pathologic patients who fit into the intended use population of the CPM System.

Conditions

  • Cardiopulmonary Disease

Interventions

DIAGNOSTIC_TEST

Noninterventional and noninvasive

The ADI At-Home CPM (Cardiopulmonary Management) System is intended for adults undergoing monitoring for cardiopulmonary conditions under the direction of a licensed medical professional to measure, record, and periodically transmit physiological data.

Sponsors & Collaborators

  • MCRA

    collaborator INDUSTRY

  • Analog Device, Inc.

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-11-19
Primary Completion
2021-02-09
Completion
2021-02-16
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04865640 on ClinicalTrials.gov