Clinical Evaluation of the Zynex Monitoring System, Model CM-1600

Completed · Not applicable

Conditions studied: Fluid Loss

In brief

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.

Key facts

Study ID

NCT05740644

Run by

Zynex Monitoring Solutions

People needed

20

Starts

2023-02-13

Expected to finish

2023-02-22

Last updated by the study team

2024-07-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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:
• History of cardiovascular surgery
• History of chest pain (angina)
• Heart rhythms other than a normal sinus rhythm or respiratory sinus arrhythmia
• History heart attack/myocardial infarction
• Peripheral arterial disease
• Carotid artery disease
• Unexplained shortness of breath
• Congestive heart failure (CHF)
• History of stroke/transient ischemic attack
• Myocardial ischemia
• Cardiomyopathy
• Dextrocardia
• Participants with clotting disorders such as:
• Hemophilia

Where it is running

• Clinimark — Louisville, Colorado, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.