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NCT02140905 · ClinicalTrials.gov registry record
Neck-Worn Monitoring Sensor for - A Study for Monitoring Subjects With Fluid-Management Issues During Dialysis
A clinical trial, sponsored by Baxter Healthcare Corporation.
- Completed
- Registry status
- 49
- Enrollment target
NCT02140905: Completed study, sponsored by Baxter Healthcare Corporation.
NCT02140905 is a clinical trial that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 49 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02140905 has completed, sponsored by Baxter Healthcare Corporation.
- COMPLETED
- Registry status
- 49 participants
- Enrollment target
Study Summary
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.
Primary Outcome
The study's primary objective is to determine the effectiveness of SFI measurements made by the Neck-Worn Monitoring System for characterizing fluid levels compared to an FDA approved device. Data collected includes SFI from the Neck-Worn Monitoring System and a reference device, fluid extracted during a dialysis session. Data will be collected every 15 minutes.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 49 participants |
| Start Date | 2014-04 |
| Est. Completion | 2014-05 |
What the finished NCT02140905 record still lists
NCT02140905 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 49 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02140905 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02140905 about?
NCT02140905 is a clinical study titled "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...
What is the current status of trial NCT02140905?
This trial is currently completed. The enrollment target is 49 participants. The study started on 2014-04. Estimated completion is 2014-05.
Who is sponsoring clinical trial NCT02140905?
This trial is sponsored by Baxter Healthcare Corporation, which has 46 total clinical trials registered on ClinicalTrials.gov.
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