Clinical Evaluation of the Zynex Monito… | Clinical Trial

Key information

Conditions

Fluid Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinimark

Louisville, Colorado, 80027, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CM-1600

Device

Healthy subjects undergoing a manual blood loss of up to 500mL followed by an infusion of 1 liter of normal saline will be connected to the CM-1600 device.

Primary outcomes

CM-1600 Ability to Detect Minor Blood Loss

Time frame: Duration of Recovery Period following blood draw (10 minutes)

The objective of this study is to determine if manual blood loss of up to 500mL of blood can be identified using the non-invasive Zynex CM-1600. This will be measured by determining the percent change in Relative Index (RI) before and after the Blood Draw. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.
CM-1600 Ability to Detect Saline Reinfusion

Time frame: Recovery period following saline reinfusion (10 minutes)

The objective of this study is to determine if a saline reinfusion of 1000mL of normal saline can be identified using the non-invasive Zynex CM-1600. This will be measured by determining the percent change in Relative Index (RI) before and after the Saline Reinfusion. The RI is an investigational value which utilizes proprietary algorithms to combine the changes of multiple measured parameters (utilizing a weighted summation of percent change values) which are indicative of relative changes in fluid volume in adult patients into a single value. The RI is a unitless value with no set minimum or maximum, where 100 is a patient's baseline. Based on the nature of the RI itself, a direct interpretation of a positive or negative outcome cannot be derived from the absolute value, instead it could be used to monitor trending of a patient's parameters relative to their baseline.

Sponsors and collaborators

Lead sponsor

Zynex Monitoring Solutions

Industry

Registry information

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Feb 23, 2023
Registry last updated: Jul 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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