Clinical Evaluation of the Zynex Monitoring System, Model CM-1600 (NCT05740644) | Clinical Trial Compass
CompletedNot Applicable
Clinical Evaluation of the Zynex Monitoring System, Model CM-1600
United States20 participantsStarted 2023-02-13
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participant must have the ability to understand the parameters of participation and provide written informed consent
* Male or female of any race
* Participant is adult 18 or older
* Participant must be willing and able to comply with study procedures and duration
* In the Principal Investigator's medical judgment, the participant is suitable for a blood draw of up to 500mL
* Participant must weigh at least 110 pounds
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 pressur…
What they're measuring
1
CM-1600 Ability to Detect Minor Blood Loss
Timeframe: Duration of Recovery Period following blood draw (10 minutes)
2
CM-1600 Ability to Detect Saline Reinfusion
Timeframe: Recovery period following saline reinfusion (10 minutes)