Neck-Worn Monitoring Sensor for - A Study for Monitoring Subjects With Fluid-Management Issues During Dialysis
Completed
Conditions studied: Heart Failure, Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT02140905
- Run by
- Baxter Healthcare Corporation
- People needed
- 49
- Starts
- 2014-04-01
- Expected to finish
- 2014-05-01
- Last updated by the study team
- 2014-05-20
Who can join
Age: 21 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Dialysis Center, Inc. — North Brunswick, New Jersey, United States
Full record on ClinicalTrials.gov
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