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
  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

Resource links provided by NLM:


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
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: 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 October 19, 2014