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Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01834612
Recruitment Status : Completed
First Posted : April 18, 2013
Last Update Posted : July 21, 2021
Sponsor:
Information provided by (Responsible Party):
Zynex Monitoring Solutions

Study Description
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Brief Summary:
To determine if a manual blood loss can be detected using the non-invasive blood monitor.

Condition or disease Intervention/treatment Phase
Blood Loss Device: CM1500 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the Zynex Blood Volume Monitor (CM1500) in Healthy Adult Volunteers During a Blood Draw
Actual Study Start Date : January 7, 2013
Actual Primary Completion Date : March 11, 2013
Actual Study Completion Date : March 11, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Blood draw
CM1500 with blood draw
 Device: CM1500
blood volume monitor
Sham Comparator: No blood draw
CM 1500 with no blood draw
 Device: CM1500
blood volume monitor


Outcome Measures
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Primary Outcome Measures :
  1. Detect change in blood volume by non-invasive monitoring during whole blood draw [ Time Frame: 4 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteer
  • between 18 to 50 years of age
  • weight between 157 to 220 lbs

Exclusion Criteria:

  • unstable or untreated cardia disease
  • alcohol consumption in 24 hours prior to screening
  • tobacco use in 4 hours prior to screening
  • pregnancy
  • infection
  • Hemoglobin < 12.5 g/dL at time of procedure
Contacts and Locations
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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): NCT01834612


Locations
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United States, Colorado
DaVita Clinical Research
Lakewood, Colorado, United States, 80228
Sponsors and Collaborators
Zynex Monitoring Solutions
Investigators
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Principal Investigator: Chris Galloway, MD Davita Clinical Research
More Information
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Responsible Party: Zynex Monitoring Solutions
ClinicalTrials.gov Identifier: NCT01834612    
Other Study ID Numbers: Zynex 750
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: July 21, 2021
Last Verified: July 2021
Keywords provided by Zynex Monitoring Solutions:
blood loss, hemorrhage, hemorrhagic shcok
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes