CompletedNCT03463148Updated Jan 20, 2022

Validation of a Sensor for Non-Invasive Measurements

An observational study in CHF, Renal Disease and Hypertension, sponsored by Baxter Healthcare Corporation. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-20.

Sponsored by Baxter Healthcare Corporation · Observational

Study type: Observational
Model: Cohort
Time perspective: Retrospective
Enrollment: 136
Ages: 18 Years and older
Sex: All

Study summary

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

Read the 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.

Conditions studied

CHF
Renal Disease
Hypertension

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Sampling method: Non-probability sample

Study population

Men and women over 22 years of age

Inclusion criteria

Subject is at least 18 (eighteen) years of age at screening.
Subject and/or legally authorized person/representative is willing to undergo the Informed Consent process prior to enrollment in the study.
Subject selection will not be based on age, height, or weight.
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

Exclusion Criteria:

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

Study design

Observational model: Cohort
Time perspective: Retrospective
Enrollment: 136 participants (actual)
Patient registry: No

Groups and cohorts

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

What researchers measure

Primary outcomes

Comparison of Blood Pressure Measurement from Sensor with Human Auscultation measurement of Blood Pressure.
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.
Time frame: 3-36 Months
Fluids
Observation of fluid measurement from Sensor (ohms)
Time frame: 3-36 Months
Heart Rate
Observation of heart rate measurement from Sensor (beats/min)
Time frame: 3-36 Months
Heart Rate Variability
Observation of heart rate variability from Sensor (milliseconds)
Time frame: 3-36 Months
Respiration Rate
Observation of respiration rate from Sensor (breaths/min)
Time frame: 3-36 Months

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT03463148
Lead sponsor: Baxter Healthcare Corporation
Responsible party: Sponsor
First posted: Mar 13, 2018
Start date: Oct 24, 2017
Primary completion: Apr 19, 2021
Completion: Apr 19, 2021
Last update: Jan 20, 2022

Study contacts

Matthew Banet, PhD

principal investigator · Baxter Healthcare Corporation

Oversight

FDA-regulated drug: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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