Validation of a Sensor for Non-Invasive Measurements

NCT03463148 | Completed

• 1 other identifier: TS-IRB-0003
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

CHF; Renal Disease; Hypertension

Outcome Measures

Primary Outcomes (5)

• 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

• Fluids

  Observation of fluid measurement from Sensor (ohms)

  3-36 Months

• Heart Rate

  Observation of heart rate measurement from Sensor (beats/min)

  3-36 Months

• Heart Rate Variability

  Observation of heart rate variability from Sensor (milliseconds)

  3-36 Months

• Respiration Rate

  Observation of respiration rate from Sensor (breaths/min)

  3-36 Months

Study Arms (1)

1

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women over 22 years of age

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Baxter Healthcare Corporation: lead

Study Sites (1)

toSense, Inc. Headquarters

San Diego, California, 92121, United States

Location

MeSH Terms

Conditions

Kidney Diseases; Hypertension

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Matthew Banet, PhD

  Baxter Healthcare Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: March 13, 2018
• Study Start: October 24, 2017
• Primary Completion: April 19, 2021
• Study Completion: April 19, 2021
• Last Updated: January 20, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)