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

Not Applicable

Completed

• Conditions: Fluid Loss
• Interventions: Device: CM-1600

• Registration Number: NCT05463198
• Lead Sponsor: Zynex Monitoring Solutions

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-14
• Study First Submitted QC: 2022-07-14
• Study First Posted: 2022-07-18
• Study Start: 2022-09-14
• Primary Completion: 2023-04-27
• Study Completion: 2023-05-26
• Results First Submitted: 2024-06-20
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Results First Posted: 2024-08-13
• Last Update Posted: 2024-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 351

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood Loss	CM-1600	-

Primary Outcome Measures

Name	Time	Method
Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL)	Recovery period following donation (10 minutes)	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.

Trial Locations

Locations (4)

Vitalant Research Institute; 🇺🇸 Denver, Colorado, United States

Blood Assurance; 🇺🇸 Chattanooga, Tennessee, United States

SunCoast Blood Centers; 🇺🇸 Bradenton, Florida, United States

ClinCept, LLC; 🇺🇸 Columbus, Georgia, United States