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

NCT05463198 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 351

Last updated 2024-08-13

Study results available
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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

Interventions

DEVICE

CM-1600

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

Sponsors & Collaborators

  • Zynex Monitoring Solutions

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-09-14
Primary Completion
2023-04-27
Completion
2023-05-26
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05463198 on ClinicalTrials.gov