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

Zynex Monitoring Solutions

Status: Completed

Conditions: Fluid Loss

Treatments: Device: CM-1600

Study type: Interventional

Funder types: Industry

Identifiers

NCT05740644

PR 2022-516

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 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
  • History of blood clots
  • History of bleeding problems
  • Bruises easily

• Self-reported health conditions as identified in the Health Assessment Form including:

  • Diabetes
  • Uncontrolled thyroid disease
  • Kidney disease / chronic renal impairment
  • History of seizures (except childhood febrile seizures)
  • Epilepsy
  • History of unexplained syncope
  • Recent history of frequent migraine headache within the last 2 months
  • Recent head injury within the last 2 months
  • History of cancer, with or without chemotherapy within the last 2 months

• Other known health conditions deemed unsuitable for participation by the PI when considered upon disclosure on health assessment form

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Blood Loss and Saline Infusion

Experimental group

Treatment:

Device: CM-1600