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

Z

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)

20 participants in 1 patient group

Blood Loss and Saline Infusion
Experimental group
Treatment:
Device: CM-1600

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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