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

Sponsor
Zynex Monitoring Solutions (Industry)
Overall Status
Completed
CT.gov ID
NCT05740644
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
9
Actual Duration (Days)
67.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: CM-1600
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Clinical Evaluation of the Zynex Monitoring System, Model CM-1600
Actual Study Start Date :
Feb 13, 2023
Actual Primary Completion Date :
Feb 22, 2023
Actual Study Completion Date :
Feb 22, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Blood Loss and Saline Infusion

Device: 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.

Outcome Measures

Primary Outcome Measures

  1. Specificity and sensitivity of minor blood loss detection and saline reinfusion [24 - 36 hours]

    The objective of this study is to determine if manual blood loss of up to 500mL of blood and re-infusion of saline can be identified using the non-invasive Zynex CM-1600.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinimark Louisville Colorado United States 80027

Sponsors and Collaborators

  • Zynex Monitoring Solutions

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Zynex Monitoring Solutions
ClinicalTrials.gov Identifier:
NCT05740644
Other Study ID Numbers:
  • PR 2022-516
First Posted:
Feb 23, 2023
Last Update Posted:
Feb 27, 2023
Last Verified:
Feb 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Feb 27, 2023