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

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ClinicalTrials.gov Identifier: NCT01834612
Recruitment Status : Unknown
Verified April 2013 by Zynex Monitoring Solutions.
Recruitment status was:  Recruiting
First Posted : April 18, 2013
Last Update Posted : April 19, 2013
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)
Estimated Enrollment : 40 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
Study Start Date : January 2013
Estimated Primary Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Contacts
Contact: Chris Galloway, MD 303-566-3002

Locations
United States, Colorado
DaVita Clinical Research Recruiting
Lakewood, Colorado, United States, 80228
Contact: Mary Cook, RN, BSN    303-566-3002      
Principal Investigator: Chris Galloway, MD         
Sponsors and Collaborators
Zynex Monitoring Solutions
Investigators
Principal Investigator: Chris Galloway, MD Davita Clinical Research
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Zynex Monitoring Solutions
ClinicalTrials.gov Identifier: NCT01834612     History of Changes
Other Study ID Numbers: Zynex 750
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: April 19, 2013
Last Verified: April 2013

Keywords provided by Zynex Monitoring Solutions:
blood loss, hemorrhage, hemorrhagic shcok

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes