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Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zynex Monitoring Solutions
ClinicalTrials.gov Identifier:
NCT01646060
First received: November 28, 2011
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood volume and blood loss of a patient during surgery, post operatively and/or in recovery. This monitoring device will identify baseline blood volume and relative changes in blood volume using a specific algorithm to compare and review data already monitored during surgery, displaying blood volume and blood loss in real-time.


Condition Intervention Phase
Blood Loss
Healthy
 Device: CM-1500
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/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 Male Adult Subjects During a Blood Draw

Further study details as provided by Zynex Monitoring Solutions:

Primary Outcome Measures:
  • Detect change in blood volume during blood draw [ Time Frame: 15-30 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Detect insidious bleeding [ Time Frame: 15-30 minutes ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: November 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blood Draw Device: CM-1500
Blood Volume Monitor

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Written informed consent
  • Male, 18-65 years of age
  • Subject is suitable for a blood draw of a pint of blood
  • Weighs at least 110 pounds

Exclusion Criteria:

  • Subject has a heart condition that may interfere with the Zynex CM-1500
  • Subject has unstable or untreated heart disease
  • Subject has been diagnosed with chronic fatigue syndrome
  • Subject is taking coumadin (warfarin), heparin, or other prescription blood thinners for at least 7 days prior to blood draw
  • Subject donated blood within 8 weeks prior to blood draw
  • Subject has high or low blood pressure on the day of blood draw
  • Subject hemoglobin < 12.5 g/dL
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646060

Locations
United States, Colorado
Rocky Mountain Urgent Care
Aurora, Colorado, United States, 80012
Sponsors and Collaborators
Zynex Monitoring Solutions
Investigators
Principal Investigator: Nathaniel Moore, MD Rocky Mountain Urgent Care
  More Information

No publications provided

Responsible Party: Zynex Monitoring Solutions
ClinicalTrials.gov Identifier: NCT01646060     History of Changes
Other Study ID Numbers: ZM-11-01
Study First Received: November 28, 2011
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Zynex Monitoring Solutions:
blood
loss
healthy
volume
To evaluate the ability of the Zynex BVM to non-invasively detect blood loss in healthy subjects during a blood draw.

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013