Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw

NCT ID: NCT01846195

Last Updated: 2022-11-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-06

Study Completion Date

2013-03-20

Brief Summary

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Non-invasive monitoring to measure changes in blood volume.

Detailed Description

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Conditions

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Blood Loss

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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no blood draw

CM 1500 with no blood draw

Group Type SHAM_COMPARATOR

CM 1500

Intervention Type DEVICE

blood draw

CM 1500 with blood draw

Group Type ACTIVE_COMPARATOR

CM 1500

Intervention Type DEVICE

Interventions

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CM 1500

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Healthy volunteers
* Between 18-35 years of age
* Weight between 130-200 pounds

Exclusion Criteria

* Known cardiac disease
* Recent caffeine intake
* Tobacco use in the (4) hours prior to screening
* Infection
* Pregnancy
* Hemoglobin \<13.5 g/dl
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DTarget

UNKNOWN

Sponsor Role collaborator

Zynex Monitoring Solutions

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Ziegler, MD

Role: PRINCIPAL_INVESTIGATOR

Premier Research Group plc

Locations

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Premier Research Group

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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Zynex500

Identifier Type: -

Identifier Source: org_study_id

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