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

Completed · Not applicable

Conditions studied: Fluid Loss

In brief

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.

Key facts

Study ID

NCT05463198

Run by

Zynex Monitoring Solutions

People needed

351

Starts

2022-09-14

Expected to finish

2023-05-26

Last updated by the study team

2024-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

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

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.