Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03072732
Other study ID # 2016-KM-004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 3, 2016
Est. completion date February 1, 2017

Study information

Verified date October 2020
Source Zoll Medical Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Device:
u-Cor System
Monitoring System
ZOE Fluid Status Monitor
Monitoring System

Locations

Country Name City State
United States DaVita Clinical Research Lakewood Colorado
United States DaVita Clinical Research Minneapolis Minnesota
United States Orlando Clinical Research Center Orlando Florida

Sponsors (1)

Lead Sponsor Collaborator
Zoll Medical Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in Correlation of Thoracic Impedance With Ultra-filtration Volume (UFV) Between uCor and ZOE 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. 15 minutes prior the start of one hemodialysis session to 15 minutes post completion of one hemodialysis session, approximately 2 to 6 hours.
See also
  Status Clinical Trial Phase
Completed NCT04780490 - Comparison of Liberal and Restrictive Fluid Management on the Endothelial Glycocalyx in Radical Cystectomy N/A
Completed NCT06405282 - Weightlessness Associated Cephalad Fluid Shifts; The Potential to Evaluate Venous and Lymphatic Dysfunction