We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

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 : 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):

Study Description
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

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

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

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

Eligibility Criteria

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

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