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This is a prospective, single-arm, non-randomized, non-controlled single-center study for the evaluation of the Zynex CM-1600 in 20 healthy adults undergoing a manual blood loss of up to 500mL followed by an infusion of 1 liter of normal saline.
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Inclusion criteria
Exclusion criteria
Any upper extremity amputation
Females who are pregnant, who are trying to get pregnant, or have a urine test positive for pregnancy on the day of the study
Participant has a heart condition that may interfere with the Zynex CM-1600 (e.g., pacemakers, defibrillator, irregular heartbeat, dextrocardia, etc.)
Participant has been diagnosed with chronic fatigue syndrome (also known as chronic fatigue, immune dysfunction syndrome, or myalgic encephalomyelitis)
Participant requires equipment and/or devices that may interfere with the Zynex CM-1600 (e.g., life-sustaining equipment, other monitoring devices, insulin pumps, or other implanted devices)
Participant is taking coumadin (warfarin), heparin, or other prescription blood thinners for 7 or more days prior to blood draw
Participant donated blood within 8 weeks prior to the study blood draw
Participant has high or low blood pressure on the day of blood draw (high blood pressure is defined as systolic > 180 mmHg or diastolic > 100 mmHg; low blood pressure is defined as systolic < 100 mmHg or diastolic < 60 mmHg)
Participant has symptoms of an active infection or a temperature ≥ 100 °F
Female with hemoglobin levels of less than 12.1g/dL or male with hemoglobin levels of less than 13.8g/dL
Participants with self-reported heart or cardiovascular conditions such as:
Participants with clotting disorders such as:
Self-reported health conditions as identified in the Health Assessment Form including:
Other known health conditions deemed unsuitable for participation by the PI when considered upon disclosure on health assessment form
Primary purpose
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Interventional model
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20 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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