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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Zynex Monitoring Solutions
Sponsor:
Information provided by (Responsible Party):
Zynex Monitoring Solutions
ClinicalTrials.gov Identifier:
NCT01834612
First received: April 15, 2013
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  Purpose

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:

MedlinePlus related topics: Bleeding
U.S. FDA Resources

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

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Zynex Monitoring Solutions
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on March 02, 2015