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

October 13, 2022 updated by: Zynex Monitoring Solutions

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

Non-invasive monitoring to measure changes in blood volume.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Premier Research Group

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 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

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: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: no blood draw
CM 1500 with no blood draw
Device: CM 1500
Active Comparator: blood draw
CM 1500 with blood draw
Device: CM 1500

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw
Time Frame: At study completion (completion of blood draw)
Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw
At study completion (completion of blood draw)

Collaborators and Investigators

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

Sponsor

Zynex Monitoring Solutions

Collaborators

DTarget

Investigators

  • Principal Investigator: John Ziegler, MD, Premier Research Group plc

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 (Actual)

June 6, 2012

Primary Completion (Actual)

March 20, 2013

Study Completion (Actual)

March 20, 2013

Study Registration Dates

First Submitted

March 13, 2013

First Submitted That Met QC Criteria

April 30, 2013

First Posted (Estimate)

May 3, 2013

Study Record Updates

Last Update Posted (Actual)

November 9, 2022

Last Update Submitted That Met QC Criteria

October 13, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zynex500

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

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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