NCT01646060CompletedPhase 1
Clinical Evaluation of the Zynex Blood Volume Monitor (CM-1500) in Healthy Male Adult Subjects During a Blood Draw
Zynex Monitoring Solutions2 sites in 1 country10 target enrollmentStarted: November 1, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Detect change in blood volume during blood draw
Study Overview
Brief Summary
Zynex's blood volume monitor (BVM) is a non-invasive monitoring device to monitor blood volume and blood loss of a patient during surgery, post operatively and/or in recovery. This monitoring device will identify baseline blood volume and relative changes in blood volume using a specific algorithm to compare and review data already monitored during surgery, displaying blood volume and blood loss in real-time.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Written informed consent
- •Male, 18-65 years of age
- •Subject is suitable for a blood draw of a pint of blood
- •Weighs at least 110 pounds
Exclusion Criteria
- •Subject has a heart condition that may interfere with the Zynex CM-1500
- •Subject has unstable or untreated heart disease
- •Subject has been diagnosed with chronic fatigue syndrome
- •Subject is taking coumadin (warfarin), heparin, or other prescription blood thinners for at least 7 days prior to blood draw
- •Subject donated blood within 8 weeks prior to blood draw
- •Subject has high or low blood pressure on the day of blood draw
- •Subject hemoglobin < 12.5 g/dL
Outcomes
Primary Outcomes
Detect change in blood volume during blood draw
Time Frame: 15-30 minutes
Secondary Outcomes
- Detect insidious bleeding(15-30 minutes)
Investigators
Study Sites (2)
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