Back to resultsEvaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw
Primary Purpose
Blood Loss
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CM1500
Sponsored by
About this trial
This is an interventional diagnostic trial for Blood Loss focused on measuring blood loss, hemorrhage, hemorrhagic shcok
Eligibility Criteria
Inclusion Criteria:
- healthy volunteer
- between 18 to 50 years of age
- weight between 157 to 220 lbs
Exclusion Criteria:
- unstable or untreated cardia disease
- alcohol consumption in 24 hours prior to screening
- tobacco use in 4 hours prior to screening
- pregnancy
- infection
- Hemoglobin < 12.5 g/dL at time of procedure
Sites / Locations
- DaVita Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Blood draw
No blood draw
Arm Description
CM1500 with blood draw
CM 1500 with no blood draw
Outcomes
Primary Outcome Measures
Detect change in blood volume by non-invasive monitoring during whole blood draw
Secondary Outcome Measures
Full Information
NCT ID
NCT01834612
First Posted
April 15, 2013
Last Updated
July 14, 2021
Sponsor
Zynex Monitoring Solutions
1. Study Identification
Unique Protocol Identification Number
NCT01834612
Brief Title
Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw
Official Title
Clinical Evaluation of the Zynex Blood Volume Monitor (CM1500) in Healthy Adult Volunteers During a Blood Draw
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2013 (Actual)
Primary Completion Date
March 11, 2013 (Actual)
Study Completion Date
March 11, 2013 (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
To determine if a manual blood loss can be detected using the non-invasive blood monitor.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss
Keywords
blood loss, hemorrhage, hemorrhagic shcok
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blood draw
Arm Type
Active Comparator
Arm Description
CM1500 with blood draw
Arm Title
No blood draw
Arm Type
Sham Comparator
Arm Description
CM 1500 with no blood draw
Intervention Type
Device
Intervention Name(s)
CM1500
Intervention Description
blood volume monitor
Primary Outcome Measure Information:
Title
Detect change in blood volume by non-invasive monitoring during whole blood draw
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy volunteer
between 18 to 50 years of age
weight between 157 to 220 lbs
Exclusion Criteria:
unstable or untreated cardia disease
alcohol consumption in 24 hours prior to screening
tobacco use in 4 hours prior to screening
pregnancy
infection
Hemoglobin < 12.5 g/dL at time of procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris Galloway, MD
Organizational Affiliation
Davita Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
DaVita Clinical Research
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80228
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw
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