ClinicalTrials.Veeva

Menu

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

Z

Zynex Monitoring Solutions

Status

Completed

Conditions

Fluid Loss

Treatments

Device: CM-1600

Study type

Interventional

Funder types

Industry

Identifiers

NCT05463198
ZMS-1600-Blood Loss Detection

Details and patient eligibility

About

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.

Enrollment

351 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

351 participants in 1 patient group

Blood Loss
Experimental group
Treatment:
Device: CM-1600

Trial documents
1

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems