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

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.

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Key information

Conditions

Blood Loss Healthy Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Rocky Mountain Urgent Care

Aurora, Colorado, 80012, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

CM-1500

Device

Blood Volume Monitor

Primary outcomes

Detect change in blood volume during blood draw

Time frame: 15-30 minutes

Secondary outcomes

Detect insidious bleeding

Time frame: 15-30 minutes

Sponsors and collaborators

Lead sponsor

Zynex Monitoring Solutions

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Jul 20, 2012
Registry last updated: Jul 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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