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OpenTrials
Completed

NCT Number: NCT03463148

Validation of a Sensor for Non-Invasive Measurements

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

Completed

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Key information

Conditions

CHF Cardiovascular Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hypertension Kidney Diseases Male Urogenital Diseases Renal Disease Urogenital Diseases Urologic Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

toSense, Inc. Headquarters

San Diego, California, 92121, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. Fluids

    Time frame: 3-36 Months

    Observation of fluid measurement from Sensor (ohms)

  3. Heart Rate

    Time frame: 3-36 Months

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

  4. Heart Rate Variability

    Time frame: 3-36 Months

    Observation of heart rate variability from Sensor (milliseconds)

  5. Respiration Rate

    Time frame: 3-36 Months

    Observation of respiration rate from Sensor (breaths/min)

Sponsors and collaborators

Lead sponsor

Baxter Healthcare Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Mar 13, 2018
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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