Validation of a Sensor for Non-Invasive Measurements

Baxter

Status: Completed

Conditions: Hypertension; CHF; Renal Disease

Study type: Observational

Funder types: Industry

Identifiers

NCT03463148

TS-IRB-0003

Details and patient eligibility

About

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

Full 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.

Enrollment: 136 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

136 participants in 1 patient group

1

Description:

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