Necklace-Shaped Sensor for Non-Invasive Remote Monitoring of Vitals

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

109 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2015-05-31

Brief Summary

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This study is designed to validate the use of the CoVa Monitoring System in subjects with implanted devices.

Detailed Description

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The study had the following objectives:

1. Verify that the CoVa Monitoring System does not interfere with implanted devices.
2. Verify that implanted devices do not interfere with the functions of the CoVa Monitoring System.
3. Verify that the CoVa Monitoring System fits on a wide variety of body types.

Conditions

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Heart Failure Hypertension

Keywords

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Hypertension Heart Failure Fluids

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1

Subjects will have a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Subject is between 21 (twenty-one) and 95 (ninety-five) years of age at screening.
* Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist device.
* Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
* Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition.

Exclusion Criteria

* Subject is participating in another clinical study that may affect the results of either study.
* Subject is unable or not willing to wear electrode patches as required.
* Subject has skin sensitivity to adhesive or hydrogel materials used in electrode patches.
* Subject is considered by the PI to be medically unsuitable for study participation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew J Banet, PhD

Role: PRINCIPAL_INVESTIGATOR

Baxter Healthcare Corporation

Locations

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Imperial Cardiac Center

Imperial, California, United States

Site Status

Countries

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United States

Other Identifiers

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PERM-IRB-001-ICC

Identifier Type: -

Identifier Source: org_study_id