Status:
COMPLETED
Validation of a Sensor for Non-Invasive Measurements
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
CHF
Renal Disease
Eligibility:
All Genders
18+ years
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 su...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 24 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 19 2021
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT03463148
Start Date
October 24 2017
End Date
April 19 2021
Last Update
January 20 2022
Active Locations (1)
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1
toSense, Inc. Headquarters
San Diego, California, United States, 92121