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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Zynex Monitoring Solutions
Sponsor:
Collaborator:
DTarget
Information provided by (Responsible Party):
Zynex Monitoring Solutions
ClinicalTrials.gov Identifier:
NCT01846195
First received: March 13, 2013
Last updated: April 30, 2013
Last verified: April 2013
  Purpose

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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety to determine non-serious unanticipated adverse device events (UADEs) [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
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
  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: 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
  More Information

No publications provided

Responsible Party: Zynex Monitoring Solutions
ClinicalTrials.gov Identifier: NCT01846195     History of Changes
Other Study ID Numbers: Zynex500
Study First Received: March 13, 2013
Last Updated: April 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Zynex Monitoring Solutions:
blood loss

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on August 26, 2014