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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zynex Monitoring Solutions
ClinicalTrials.gov Identifier:
NCT01646060
First received: November 28, 2011
Last updated: July 17, 2012
Last verified: July 2012
History of Changes

November 28, 2011
July 17, 2012
November 2011
December 2011   (final data collection date for primary outcome measure)
Detect change in blood volume during blood draw [ Time Frame: 15-30 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01646060 on ClinicalTrials.gov Archive Site
Detect insidious bleeding [ Time Frame: 15-30 minutes ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw
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.
Not Provided
Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Blood Loss
  • Healthy
Device: CM-1500
Blood Volume Monitor
Experimental: Blood Draw
Intervention: Device: CM-1500
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01646060
ZM-11-01
No
Zynex Monitoring Solutions
Zynex Monitoring Solutions
Not Provided
Principal Investigator: Nathaniel Moore, MD Rocky Mountain Urgent Care
Zynex Monitoring Solutions
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP