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

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ClinicalTrials.gov Identifier: NCT01846195
Recruitment Status : Unknown
Verified April 2013 by Zynex Monitoring Solutions.
Recruitment status was:  Recruiting
First Posted : May 3, 2013
Last Update Posted : May 3, 2013
Sponsor:
Collaborator:
DTarget
Information provided by (Responsible Party):
Zynex Monitoring Solutions

Brief Summary:
Non-invasive monitoring to measure changes in blood volume.

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
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 Adult Patients During a Blood Draw
Study Start Date : September 2012
Estimated Primary Completion Date : August 2013

Arm Intervention/treatment
Sham Comparator: no blood draw
CM 1500 with no blood draw
Device: CM 1500
Active Comparator: blood draw
CM 1500 with blood draw
Device: CM 1500



Primary Outcome Measures :
  1. Detect by non-invasive monitoring a change in blood volume during a whole blood draw [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Safety to determine non-serious unanticipated adverse device events (UADEs) [ Time Frame: 12 Months ]
    This is a non-significant research and development study. Anticipated adverse effects include localized skin irritation from sensors or mild discomfort from lying supine for a prolonged period of time. All UADEs will be monitored.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • Between 18-35 years of age
  • Weight between 130-200 pounds

Exclusion Criteria:

  • Known cardiac disease
  • Recent caffeine intake
  • Tobacco use in the (4) hours prior to screening
  • Infection
  • Pregnancy
  • Hemoglobin <13.5 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): NCT01846195


Contacts
Contact: John Ziegler, MD 801-266-0815 John.Ziegler@premier-research.com

Locations
United States, Utah
Premier Research Group Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Russell Gray    801-266-0815    Russell.Gray@premier-research.com   
Principal Investigator: John Ziegler, MD         
Sponsors and Collaborators
Zynex Monitoring Solutions
DTarget
Investigators
Principal Investigator: John Ziegler, MD Premier Research Group plc

Responsible Party: Zynex Monitoring Solutions
ClinicalTrials.gov Identifier: NCT01846195     History of Changes
Other Study ID Numbers: Zynex500
First Posted: May 3, 2013    Key Record Dates
Last Update Posted: May 3, 2013
Last Verified: April 2013

Keywords provided by Zynex Monitoring Solutions:
blood loss

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes