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

July 17, 2012 updated by: Zynex Monitoring Solutions
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Urgent Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Blood Draw
Device: CM-1500
Blood Volume Monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Detect change in blood volume during blood draw
Time Frame: 15-30 minutes
15-30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Detect insidious bleeding
Time Frame: 15-30 minutes
15-30 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zynex Monitoring Solutions

Investigators

  • Principal Investigator: Nathaniel Moore, MD, Rocky Mountain Urgent Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 28, 2011

First Submitted That Met QC Criteria

July 17, 2012

First Posted (Estimate)

July 20, 2012

Study Record Updates

Last Update Posted (Estimate)

July 20, 2012

Last Update Submitted That Met QC Criteria

July 17, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZM-11-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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