Clinical Evaluation of the CM-1500 During Apheresis Blood Donation

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.

Study Overview

• Status: Completed
• Conditions: Fluid Loss
• Intervention / Treatment: Device: CM-1500; Device: CM-1600

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80230
      • Vitalant Blood Donation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apheresis Platelet Donation: CM-1500; The subjects will be connected to the CM-1500 during apheresis platelet donation	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.
Experimental: Apheresis Platelet Donation: CM-1600; The subjects will be connected to the CM-1600 during apheresis platelet donation	Device: CM-1600; The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors Bioelectrical Impedance, Photoplethysmography (PPG) Amplitude, ECG Amplitude and Skin Temperature. A combination of these parameters is represented by a single number known as the Relative Index value.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Characterize Changes in the Relative Index During an Apheresis Procedure	The objective of the study is to characterize changes in the Relative Index (RI) as a representation of its associated parameters during apheresis. This was measured by averaging the RI values after the procedure. Changes in parameters from their baseline can be used as an indicator of potential change in fluid status. This change may be reflected in the RI since it is a summated value (weighted summation of percent change) combining the changes of the parameters into a single value. In the case of fluid loss such as apheresis the RI value may decrease as a result of changes in the parameters which can change in response to fluid status change. The RI is a unitless value with no set min. or max. Within the context of this trial trying to evaluate the RI, a decrease from 100 was considered a good outcome. However, in clinical use, the RI should not be used as an indicator of patient status, instead it could be used to monitor trending of patient parameters relative to their baseline.	Duration of apheresis procedure (e.g., 2 - 3hrs)

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

Collaborators and Investigators

• Sponsor: Zynex Monitoring Solutions
• Investigators: Principal Investigator: Samantha Mack, MD, Vitalant Blood Donation

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): December 20, 2022
• Study Completion (Actual): December 20, 2022

Study Registration Dates

• First Submitted: August 6, 2021
• First Submitted That Met QC Criteria: August 12, 2021
• First Posted (Actual): August 19, 2021

Study Record Updates

• Last Update Posted (Actual): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: ZMS-1500-2021-Apheresis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes