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NCT03072732 · ClinicalTrials.gov registry record · NA
Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System
A NA study, sponsored by Zoll Medical Corporation.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT03072732 is a NA study that has completed, run by Zoll Medical Corporation. The registered enrollment target is 40 participants.
The verdict
NCT03072732, a NA study, has completed, sponsored by Zoll Medical Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this study is to measure the fluid changes in the body using a device called the µ-Cor System, an investigational device. The µ-Cor System will record the fluid changes in the body, as well as ECG (electrocardiogram or an electrical tracing of your heart rhythm) heart rate, breathing rate, posture and activity at regular intervals. The information collected by the µ-Cor System will then be compared to the actual fluid removed through dialysis and to the information collected by an FDA (Food and Drug Administration) cleared device called ZOE (NonInvasive Medical Technologies), a monitor which also measures the fluid changes in the body. The objectives of this study are to document any differences in measurement of thoracic impedance obtained from the µ-Cor System and the ZOE system. Thoracic impedance is a measure of the electrical activity in the chest that varies with changes in body size and composition, fluid volume, breathing status and other variables. Measurements of the amount of fluid removed during dialysis will also be compared between the µ-Cor System, the ZOE system and the actual fluid removed. The ability of the µ-Cor System to measure thoracic impedance will be tested by placing the device randomly at one of two locations: * Study Arm 1: side location- below left axilla * Study Arm 2: front location - upper left pectoral area Both the µ-Cor System and the ZOE System will be worn simultaneously during one dialysis session. The ZOE system device is placed on the chest- 2 points: 1 at the base of your neck and 1 in your mid chest.
Interventions
- DEVICE u-Cor System
- DEVICE ZOE Fluid Status Monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2016-11-03 |
| Est. Completion | 2017-02-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03072732
The ClinicalTrials.gov registry entry for NCT03072732 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Zoll Medical Corporation, which has 24 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which u-Cor System is the first listed.
NCT03072732 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03072732 about?
NCT03072732 is a clinical study titled "Measuring Thoracic Impedance in Hemodialysis Patients With the u-Cor Monitoring System". The purpose of this study is to measure the fluid changes in the body using a device called the µ-Cor System, an investigational device. The µ-Cor System will record the fluid changes in the body, as well as ECG (electrocardiogram or an electrical tracing of your heart rhythm) heart rate, breathing ...
What is the current status of trial NCT03072732?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2016-11-03. Estimated completion is 2017-02-01.
What interventions are being tested in trial NCT03072732?
The interventions under investigation include: u-Cor System (DEVICE), ZOE Fluid Status Monitor (DEVICE).
Who is sponsoring clinical trial NCT03072732?
This trial is sponsored by Zoll Medical Corporation, which has 24 total clinical trials registered on ClinicalTrials.gov.
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