Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

Study Overview
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Brief Summary
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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.

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

Conditions
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Fluid Loss

Intervention / Treatment
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* Device: CM-1500


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Characterize changes in the Relative Index in right and left antecubital donations |  | 1-6 hours | 
| Characterize relative Index changes when using various apheresis devices |  | 1-6 hours | 
| 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 |