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Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers 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: April 15, 2013
Last updated: April 17, 2013
Last verified: April 2013
To determine if a manual blood loss can be detected using the non-invasive blood monitor.

Condition Intervention Phase
Blood Loss
Device: CM1500
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of the Zynex Blood Volume Monitor (CM1500) in Healthy Adult Volunteers During a Blood Draw

Resource links provided by NLM:

Further study details as provided by Zynex Monitoring Solutions:

Primary Outcome Measures:
  • Detect change in blood volume by non-invasive monitoring during whole blood draw [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
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: NCT01834612

United States, Colorado
DaVita Clinical Research
Lakewood, Colorado, United States, 80228
Sponsors and Collaborators
Zynex Monitoring Solutions
Principal Investigator: Chris Galloway, MD Davita Clinical Research
  More Information

Responsible Party: Zynex Monitoring Solutions Identifier: NCT01834612     History of Changes
Other Study ID Numbers: Zynex 750 
Study First Received: April 15, 2013
Last Updated: April 17, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Pathologic Processes processed this record on January 14, 2017