Evaluation of the Zynex Blood Volume Monitor in Healthy Adult Volunteers During a Blood Draw
The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2013 by Zynex Monitoring Solutions.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Zynex Monitoring Solutions
Information provided by (Responsible Party):
Zynex Monitoring Solutions
ClinicalTrials.gov Identifier:
NCT01834612
First received: April 15, 2013
Last updated: April 17, 2013
Last verified: April 2013
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Purpose
To determine if a manual blood loss can be detected using the non-invasive blood monitor.
| Condition | Intervention | Phase |
|---|---|---|
|
Blood Loss |
Device: CM1500 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Clinical Evaluation of the Zynex Blood Volume Monitor (CM1500) in Healthy Adult Volunteers During a Blood Draw |
Resource links provided by NLM:
Further study details as provided by Zynex Monitoring Solutions:
Primary Outcome Measures:
- Detect change in blood volume by non-invasive monitoring during whole blood draw [ Time Frame: 4 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 40 |
| Study Start Date: | January 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834612
Please refer to this study by its ClinicalTrials.gov identifier: NCT01834612
Contacts
| Contact: Chris Galloway, MD | 303-566-3002 |
Locations
| 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 | |
Sponsors and Collaborators
Zynex Monitoring Solutions
Investigators
| Principal Investigator: | Chris Galloway, MD | Davita Clinical Research |
More Information
| Responsible Party: | Zynex Monitoring Solutions |
| ClinicalTrials.gov Identifier: | NCT01834612 History of Changes |
| Other Study ID Numbers: | Zynex 750 |
| Study First Received: | April 15, 2013 |
| Last Updated: | April 17, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Zynex Monitoring Solutions:
|
blood loss, hemorrhage, hemorrhagic shcok |
Additional relevant MeSH terms:
|
Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on September 27, 2016