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

NCT ID: NCT05740644

Last Updated: 2024-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-13
• Study Completion Date: 2023-02-22

Brief 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.

Conditions

Fluid Loss

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Blood Loss and Saline Infusion

Group Type: EXPERIMENTAL

CM-1600

Intervention Type: 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.

Interventions

CM-1600

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zynex Monitoring Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinimark

Louisville, Colorado, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.zynexmonitoring.com

Related Info

Other Identifiers

PR 2022-516

Identifier Type: -

Identifier Source: org_study_id