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

Primary Purpose

Blood Loss

Status
Completed
Phase
Not Applicable
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 other trial for Blood Loss focused on measuring blood loss

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Premier Research Group

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

no blood draw

blood draw

Arm Description

CM 1500 with no blood draw

CM 1500 with blood draw

Outcomes

Primary Outcome Measures

Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw
Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw

Secondary Outcome Measures

Full Information

First Posted
March 13, 2013
Last Updated
October 13, 2022
Sponsor
Zynex Monitoring Solutions
Collaborators
DTarget
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1. Study Identification

Unique Protocol Identification Number
NCT01846195
Brief Title
Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Patients During a Blood Draw
Official Title
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Adult Patients During a Blood Draw
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 6, 2012 (Actual)
Primary Completion Date
March 20, 2013 (Actual)
Study Completion Date
March 20, 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Non-invasive monitoring to measure changes in blood volume.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
no blood draw
Arm Type
Sham Comparator
Arm Description
CM 1500 with no blood draw
Arm Title
blood draw
Arm Type
Active Comparator
Arm Description
CM 1500 with blood draw
Intervention Type
Device
Intervention Name(s)
CM 1500
Primary Outcome Measure Information:
Title
Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw
Description
Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw
Time Frame
At study completion (completion of blood draw)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Ziegler, MD
Organizational Affiliation
Premier Research Group plc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Premier Research Group
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States

12. IPD Sharing Statement

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

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