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

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ClinicalTrials.gov Identifier: NCT01646060
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : July 20, 2012
Sponsor:
Information provided by (Responsible Party):
Zynex Monitoring Solutions

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Blood Loss Healthy Device: CM-1500 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw
Study Start Date : November 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Blood Draw Device: CM-1500
Blood Volume Monitor



Primary Outcome Measures :
  1. Detect change in blood volume during blood draw [ Time Frame: 15-30 minutes ]

Secondary Outcome Measures :
  1. Detect insidious bleeding [ Time Frame: 15-30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01646060


Locations
United States, Colorado
Rocky Mountain Urgent Care
Aurora, Colorado, United States, 80012
Sponsors and Collaborators
Zynex Monitoring Solutions
Investigators
Principal Investigator: Nathaniel Moore, MD Rocky Mountain Urgent Care

Responsible Party: Zynex Monitoring Solutions
ClinicalTrials.gov Identifier: NCT01646060     History of Changes
Other Study ID Numbers: ZM-11-01
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: July 20, 2012
Last Verified: July 2012

Keywords provided by Zynex Monitoring Solutions:
blood
loss
healthy
volume
To evaluate the ability of the Zynex BVM to non-invasively detect blood loss in healthy subjects during a blood draw.

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes