Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw
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ClinicalTrials.gov Identifier: NCT01834612 |
Recruitment Status
: Unknown
Verified April 2013 by Zynex Monitoring Solutions.
Recruitment status was: Recruiting
First Posted
: April 18, 2013
Last Update Posted
: April 19, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Blood Loss | Device: CM1500 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Clinical Evaluation of the Zynex Blood Volume Monitor (CM1500) in Healthy Adult Volunteers During a Blood Draw |
Study Start Date : | January 2013 |
Estimated Primary Completion Date : | July 2013 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Blood draw
CM1500 with blood draw
|
Device: CM1500
blood volume monitor
|
Sham Comparator: No blood draw
CM 1500 with no blood draw
|
Device: CM1500
blood volume monitor
|
- Detect change in blood volume by non-invasive monitoring during whole blood draw [ Time Frame: 4 months ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834612
Contact: Chris Galloway, MD | 303-566-3002 |
United States, Colorado | |
DaVita Clinical Research | Recruiting |
Lakewood, Colorado, United States, 80228 | |
Contact: Mary Cook, RN, BSN 303-566-3002 | |
Principal Investigator: Chris Galloway, MD |
Principal Investigator: | Chris Galloway, MD | Davita Clinical Research |
Responsible Party: | Zynex Monitoring Solutions |
ClinicalTrials.gov Identifier: | NCT01834612 History of Changes |
Other Study ID Numbers: |
Zynex 750 |
First Posted: | April 18, 2013 Key Record Dates |
Last Update Posted: | April 19, 2013 |
Last Verified: | April 2013 |
Keywords provided by Zynex Monitoring Solutions:
blood loss, hemorrhage, hemorrhagic shcok |
Additional relevant MeSH terms:
Hemorrhage Pathologic Processes |