Validation of a Sensor for Non-Invasive Measurements

NCT ID: NCT03463148

Last Updated: 2022-01-20

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

136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-24

Study Completion Date

2021-04-19

Brief Summary

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Subjects will be measured with both a sensor and a reference device

Detailed Description

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Subjects will participate in a study measuring a single set of paired values. In this case, measurements will take roughly 2-30 minutes to complete, and will involve: 1) attaching the sensor on the subject; 2) attaching one or more reference devices to the subject; 3) making measurements with both the sensor and reference device, either simultaneously or sequentially; and 4) collecting and analyzing the paired value.

Conditions

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CHF Renal Disease Hypertension

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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1

Men/Women who meet the inclusion/exclusion criteria of this protocol.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Subject is at least 18 (eighteen) years of age at screening.
2. Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
3. Subject selection will not be based on age, height, or weight.
4. Subject is a candidate for this study based on the PI's opinion and knowledge of the subject's condition as well as the features of the investigational device tested during the study.

Exclusion Criteria

1. Subject is participating in another clinical study that may affect the results of either study.
2. Subjects that are pregnant will not be included in the study.
3. Subject is unable or not willing to wear electrode patches as required for a period of up to 168 hours.
4. Subject is considered by the Principal Investigator to be medically unsuitable for study participation.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baxter Healthcare Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Matthew Banet, PhD

Role: PRINCIPAL_INVESTIGATOR

Baxter Healthcare Corporation

Locations

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toSense, Inc. Headquarters

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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TS-IRB-0003

Identifier Type: -

Identifier Source: org_study_id

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