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

NCT05463198 | Completed Results FDA Device

• 1 other identifier: ZMS-1600-Blood Loss Detection
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 4

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.

Conditions

Fluid Loss

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Blood Loss

EXPERIMENTAL

Device: CM-1600

Interventions

CM-1600 DEVICE

Subjects undergoing blood donation will be connected to the CM-1600 device.

Blood Loss

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zynex Monitoring Solutions: lead

Study Sites (4)

Vitalant Research Institute

Denver, Colorado, 80230, United States

Location

SunCoast Blood Centers

Bradenton, Florida, 34211, United States

Location

ClinCept, LLC

Columbus, Georgia, 31904, United States

Location

Blood Assurance

Chattanooga, Tennessee, 37403, United States

Location

Related Links

• Related Info

Results Point of Contact

• Title: ZMS Clinical
• Organization: Zynex Monitoring Solutions

clinical@zynexmonitoring.com

800-495-6670

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: July 18, 2022
• Study Start: September 14, 2022
• Primary Completion: April 27, 2023
• Study Completion: May 26, 2023
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)