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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Zynex Monitoring Solutions.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Zynex Monitoring Solutions Identifier:
First received: March 13, 2013
Last updated: April 30, 2013
Last verified: April 2013
Non-invasive monitoring to measure changes in blood volume.

Condition Intervention Phase
Blood Loss
Device: CM 1500
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Further study details as provided by Zynex Monitoring Solutions:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01846195

United States, Utah
Premier Research Group
Salt Lake City, Utah, United States, 84107
Sponsors and Collaborators
Zynex Monitoring Solutions
Principal Investigator: John Ziegler, MD Premier Research Group plc
  More Information

Responsible Party: Zynex Monitoring Solutions Identifier: NCT01846195     History of Changes
Other Study ID Numbers: Zynex500 
Study First Received: March 13, 2013
Last Updated: April 30, 2013

Keywords provided by Zynex Monitoring Solutions:
blood loss

Additional relevant MeSH terms:
Pathologic Processes processed this record on February 17, 2017