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NCT05012462 Clinical Trial

Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

Fluid Loss Clinical Trial

Official title:
Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05012462
Other study ID # ZMS-1500-2021-Apheresis
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 20, 2021
Est. completion date December 20, 2022

Study information
Verified date December 2022
Source Zynex Monitoring Solutions
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is a prospective, single-arm, non-randomized, non-blinded, non-controlled, non-significant risk, single center study enrolling up to 200 healthy adult subjects consented to undergo an apheresis donation procedure. Subjects will be connected to the Zynex Cardiac Monitor, Model 1500 (CM-1500) to characterize changes in the relative index during an apheresis donation procedure.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date December 20, 2022
Est. primary completion date December 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ability to provide written informed consent - Ability and willingness to comply with the study procedures and duration requirements - 18 years of age or older - Consented to undergo an apheresis procedure with an automated blood component device Exclusion Criteria: - Females who are pregnant or breastfeeding - Undergone an amputation of the left upper extremity - Diagnosed with dextrocardia - Subjects who have a pacemaker

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• CM-1500
The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value. This value is indicative of relative changes in fluid volume.

Locations
Country Name City State
United States Vitalant Blood Donation Denver Colorado

Sponsors (1)
Lead Sponsor Collaborator
Zynex Monitoring Solutions

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Characterize changes in the Relative Index during an apheresis procedure The primary objective of the study is to characterize changes in the CM-1500 Relative Index over the duration of an apheresis procedure 1-6 hours
Secondary Characterize changes in blood pressure relative to changes in the Relative Index Characterize changes in blood pressure that occur during the apheresis procedure compared to the changes observed in the Relative Index during the same time period 1-6 hours
Secondary Characterize changes in the Relative Index in right and left antecubital donations 1-6 hours
Secondary Characterize relative Index changes when using various apheresis devices 1-6 hours
Secondary Characterize the CM-1500's ability to detect different blood components and fluid Examine differences in Relative Index changes depending upon the type of blood product donated and changes in the Relative Index if/when fluids are infused in subjects during the apheresis procedure 1-6 hours
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