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

NCT05740644 | Completed Results FDA Device

• 1 other identifier: PR 2022-516
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• CM-1600 Ability to Detect Minor Blood Loss

  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.

  Duration of Recovery Period following blood draw (10 minutes)

• CM-1600 Ability to Detect Saline Reinfusion

  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.

  Recovery period following saline reinfusion (10 minutes)

Study Arms (1)

Blood Loss and Saline Infusion

EXPERIMENTAL

Device: CM-1600

Interventions

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.

Blood Loss and Saline Infusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zynex Monitoring Solutions: lead

Study Sites (1)

Clinimark

Louisville, Colorado, 80027, United States

Location

Related Links

• Related Info

Results Point of Contact

• Title: Clinical Team
• Organization: Zynex Monitoring Solutions

clinical@zynexmonitoring.com

888-386-4185

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 23, 2023
• Study Start: February 13, 2023
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2023
• Last Updated: July 16, 2024
• Results First Posted: July 16, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)