Evaluation of Physiological Variables and Detection of Blood Loss Using the Zynex Fluid Monitoring System, Model CM-1600

The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure. The study will involve enrolling subjects that will undergo blood donation wearing the study device (CM-1600 Device) and capture study-required physiological parameters pre-, during, and post-donation.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 351
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80230
      • Vitalant Research Institute
  • Florida
    • Bradenton, Florida, United States, 34211
      • SunCoast Blood Centers
  • Georgia
    • Columbus, Georgia, United States, 31904
      • ClinCept, LLC
  • Tennessee
    • Chattanooga, Tennessee, United States, 37403
      • Blood Assurance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Ability to provide written consent
• Ability and willingness to comply with the study procedures and duration requirements
• 18 years of age or older
• Consented and eligible to undergo a single unit whole blood donation

Exclusion Criteria:

• Females who are pregnant or breastfeeding
• Undergone an amputation of any upper extremity
• Diagnosed with dextrocardia
• Subjects who have a pacemaker
• Subjects with body hair density which prevents adequate application of device electrodes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Blood Loss	Device: CM-1600; Subjects undergoing blood donation will be connected to the CM-1600 device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL)	The objective of this study is to determine if manual blood loss of up to 500mL of blood can be identified using the non-invasive Zynex CM-1600. This will be measured by determining the percent change in Relative Index (RI) before and after the Blood Draw. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.	Recovery period following donation (10 minutes)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Right vs left antecubital blood donation	Characterize the differences in the relative changes in right vs left antecubital blood donations	15 - 60 minutes
Correlation between physiological parameters and relative index	Investigate any possible correlations between adverse events, subject demographics, changes in the Relative Index, and timing of when the events occurred	15 - 60 minutes

Collaborators and Investigators

• Sponsor: Zynex Monitoring Solutions

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): May 26, 2023

Study Registration Dates

• First Submitted: July 14, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: July 22, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage
• Other Study ID Numbers: ZMS-1600-Blood Loss Detection

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

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.: No