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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: Completed NA study, sponsored by Zoll Medical Corporation.
NCT03072732 is a NA study that has completed, run by Zoll Medical Corporation. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint measurement is the difference of 1) the Pearson correlation of thoracic impedance made by the u-Cor System to UFV and 2) the Pearson correlation of thoracic impedance made by the ZOE to UFV. Differences in correlation coefficients were calculated for each subject and each study arm.
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 |
What the finished NCT03072732 record still lists
NCT03072732 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which u-Cor System is the first listed.
NCT03072732 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03072732's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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