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

This study is currently recruiting participants.
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
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 April 16, 2014