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

Primary Purpose

Blood Loss, Healthy

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CM-1500
Sponsored by
Zynex Monitoring Solutions
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Blood Loss focused on measuring 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.

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Rocky Mountain Urgent Care

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Blood Draw

Arm Description

Outcomes

Primary Outcome Measures

Detect change in blood volume during blood draw

Secondary Outcome Measures

Detect insidious bleeding

Full Information

First Posted
November 28, 2011
Last Updated
July 17, 2012
Sponsor
Zynex Monitoring Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT01646060
Brief Title
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw
Official Title
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zynex Monitoring Solutions

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Healthy
Keywords
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.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood Draw
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
CM-1500
Intervention Description
Blood Volume Monitor
Primary Outcome Measure Information:
Title
Detect change in blood volume during blood draw
Time Frame
15-30 minutes
Secondary Outcome Measure Information:
Title
Detect insidious bleeding
Time Frame
15-30 minutes

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nathaniel Moore, MD
Organizational Affiliation
Rocky Mountain Urgent Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rocky Mountain Urgent Care
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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