Neck-Worn Monitoring Sensor for - A Study for Monitoring Subjects With Fluid-Management Issues During Dialysis
Neck-Worn Monitoring Sensor for - A Study for Monitoring Subjects With Fluid-Management Issues During Dialysis
The study has two objectives based on the intended-use measurements and populations described
 above. The first objective is to show that relative changes in impedance as measured by the
 test device (ΔSFI) are strongly correlated with the amount of fluid removed during dialysis
 (ΔF) for subjects with ESRD and possibly Heart Failure.

 The second objective is to demonstrate correlation between ΔSFI and relative changes in
 impedance (ΔZ) as measured by the reference device.
The investigators propose a study for validating the test device's measurement of a parameter
 called 'sternal fluid index' (SFI) in patients with diagnosed medical conditions related to
 fluid management, e.g. end-stage renal disease (ESRD), that are undergoing dialysis. The
 reference device for the study measures the averaged amplitude of a thoracic bio-impedance
 signal (Z) and a parameter called 'thoracic fluid content' (TFC), which is equal to 1000/Z.
 The test device measures SFI from a localized region near the sternum, whereas the reference
 device measures Z and TFC from the entire thoracic cavity. This means Z (or TFC) and SFI, if
 measured at approximately the same time, will likely correlate but have different absolute
 values. Thus, the statistical analysis will investigate the ability of SFI to track fluids,
 as well as the agreement between fluid-dependent trends displayed by SFI and Z (or TFC), as
 described below.

 During the study the investigators will collect multiple samples, each containing a value of
 SFI from the test device, and values of TFC and Z from the reference device. The
 investigators will enroll approximately 20-50 subjects, with the goal of at least 20 subjects
 completing the study. The statistical analysis will include data from all subjects that
 complete the study. All subjects will undergo dialysis in a clinic. Approximately half to a
 third will have both ESRD and Heart Failure (HF). The investigators will measure a sample
 from each subject every 15 minutes during a standard dialysis session, which typically lasts
 about 3 to 4 hours. Levels of extracted fluids, determined by the dialysis machine, will be
 recorded at the time each sample is measured.

 The statistical model compares time-dependent changes in SFI and Z values collected during
 dialysis. It is designed is to demonstrate: 1) that the test device is effective in
 characterizing fluid levels when used as intended; and 2) that the test and reference
 devices' measurements of trends in fluids are substantially equivalent, since they sense
 different physiological regions which are expected to yield different values of impedance.
Inclusion Criteria:

 -  Subject is between 21 (twenty-one) and 90 (ninety) years of age at screening.

 -  Subject will have one or more of the following clinical diagnoses related to
 fluid-management issues: ESRD, Heart Failure.

 -  Subject and/or legally authorized person/representative is willing to undergo the
 Informed Consent process prior to enrollment in the study.

 -  Subject is a candidate for this study based on the PI's opinion and knowledge of the
 subject's condition.

 Exclusion Criteria:

 -  Subject is participating in another clinical study that may affect the results of
 either study.

 -  Subject is unable or not willing to wear electrode patches as required.

 -  Subject has skin sensitivity to adhesive or hydrogel materials used in electrode
 patches.

 -  Subject has a pacemaker, implanted cardioverter-defibrillator, or ventricular assist
 device.

 -  Subject is considered by the PI to be medically unsuitable for study participation