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

NCT ID: NCT01646060

Last Updated: 2012-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Blood Loss Healthy

Keywords

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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.

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Blood Draw

Group Type EXPERIMENTAL

CM-1500

Intervention Type DEVICE

Blood Volume Monitor

Interventions

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CM-1500

Blood Volume Monitor

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zynex Monitoring Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nathaniel Moore, MD

Role: PRINCIPAL_INVESTIGATOR

Rocky Mountain Urgent Care

Locations

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Rocky Mountain Urgent Care

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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ZM-11-01

Identifier Type: -

Identifier Source: org_study_id