Validation of a Sensor for Non-Invasive Measurements

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463148
• Other study ID #: TS-IRB-0003
• Status: Completed
• Start date: October 24, 2017
• Est. completion date: April 19, 2021

Study information

• Verified date: January 2022
• Source: Baxter Healthcare Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: April 19, 2021
• Est. primary completion date: April 19, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• CHF
• Hypertension
• Kidney Diseases
• Renal Disease

Locations

Country	Name	City	State
United States	toSense, Inc. Headquarters	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3-36 Months
Primary	Fluids	Observation of fluid measurement from Sensor (ohms)	3-36 Months
Primary	Heart Rate	Observation of heart rate measurement from Sensor (beats/min)	3-36 Months
Primary	Heart Rate Variability	Observation of heart rate variability from Sensor (milliseconds)	3-36 Months
Primary	Respiration Rate	Observation of respiration rate from Sensor (breaths/min)	3-36 Months