Validation of a Sensor for Non-Invasive Measurements

Completed

• Conditions: CHF; Renal Disease; Hypertension

• Registration Number: NCT03463148
• Lead Sponsor: Baxter Healthcare Corporation

Brief Summary

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

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 Timeline

• Study Start: 2017-10-24
• Study First Submitted: 2018-01-31
• Study First Submitted QC: 2018-03-09
• Study First Posted: 2018-03-13
• Primary Completion: 2021-04-19
• Study Completion: 2021-04-19
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-19
• Last Update Posted: 2022-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

toSense, Inc. Headquarters; 🇺🇸 San Diego, California, United States