Validation of a Sensor for Non-Invasive Measurements

January 19, 2022 updated by: Baxter Healthcare Corporation

Validation of a Sensor for Non-Invasive Measurement of Vital Signs, Hemodynamic Parameters and Time-Dependent Physiological Waveforms

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

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92121
        • toSense, Inc. Headquarters

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Men and women over 22 years of age

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Men/Women who meet the inclusion/exclusion criteria of this protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Blood Pressure Measurement from Sensor with Human Auscultation measurement of Blood Pressure.
Time Frame: 3-36 Months
Comparison of Blood Pressure Measurement from Sensor with Human Auscultation measurement of Blood Pressure. Specifically, Systolic Blood Pressure and Diastolic Blood Pressure with units of millimeters of mercury (mmHg) will be compared.
3-36 Months
Fluids
Time Frame: 3-36 Months
Observation of fluid measurement from Sensor (ohms)
3-36 Months
Heart Rate
Time Frame: 3-36 Months
Observation of heart rate measurement from Sensor (beats/min)
3-36 Months
Heart Rate Variability
Time Frame: 3-36 Months
Observation of heart rate variability from Sensor (milliseconds)
3-36 Months
Respiration Rate
Time Frame: 3-36 Months
Observation of respiration rate from Sensor (breaths/min)
3-36 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

Investigators

  • Principal Investigator: Matthew Banet, PhD, Baxter Healthcare Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2017

Primary Completion (Actual)

April 19, 2021

Study Completion (Actual)

April 19, 2021

Study Registration Dates

First Submitted

January 31, 2018

First Submitted That Met QC Criteria

March 9, 2018

First Posted (Actual)

March 13, 2018

Study Record Updates

Last Update Posted (Actual)

January 20, 2022

Last Update Submitted That Met QC Criteria

January 19, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TS-IRB-0003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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