Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw

Completed · Phase 1

Conditions studied: Blood Loss, Healthy

In brief

Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood volume and blood loss of a patient during surgery, post operatively and/or in recovery. This monitoring device will identify baseline blood volume and relative changes in blood volume using a specific algorithm to compare and review data already monitored during surgery, displaying blood volume and blood loss in real-time.

Key facts

Study ID

NCT01646060

Run by

Zynex Monitoring Solutions

People needed

10

Starts

2011-11-01

Expected to finish

2011-12-01

Last updated by the study team

2012-07-20

Who can join

Age: 18 and older, up to 65. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• Written informed consent
• Male, 18-65 years of age
• Subject is suitable for a blood draw of a pint of blood
• Weighs at least 110 pounds

You may not qualify if…

• Subject has a heart condition that may interfere with the Zynex CM-1500
• Subject has unstable or untreated heart disease
• Subject has been diagnosed with chronic fatigue syndrome
• Subject is taking coumadin (warfarin), heparin, or other prescription blood thinners for at least 7 days prior to blood draw
• Subject donated blood within 8 weeks prior to blood draw
• Subject has high or low blood pressure on the day of blood draw
• Subject hemoglobin < 12.5 g/dL

Where it is running

• Rocky Mountain Urgent Care — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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