NCT01834612CompletedPhase 1
Clinical Evaluation of the Zynex Blood Volume Monitor (CM1500) in Healthy Adult Volunteers During a Blood Draw
Zynex Monitoring Solutions2 sites in 1 country20 target enrollmentStarted: January 7, 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Detect change in blood volume by non-invasive monitoring during whole blood draw
Study Overview
Brief Summary
To determine if a manual blood loss can be detected using the non-invasive blood monitor.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Detect change in blood volume by non-invasive monitoring during whole blood draw
Time Frame: 4 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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