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CompletedNCT05740644Updated Jul 16, 2024Results posted

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

An interventional study of CM-1600 in Fluid Loss, sponsored by Zynex Monitoring Solutions. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-16.

Sponsored by Zynex Monitoring Solutions · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Fluid Loss
03

In context

Lead sponsor

Zynex Monitoring Solutions is the lead sponsor of 8 studies on the registry; none are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Blood Loss and Saline Infusion

    Device: CM-1600

Interventions

  • DeviceCM-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.

06

What researchers measure

Primary outcomes

  1. 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.

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

  2. 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.

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

07

Results

Posted Jul 16, 2024

Participant flow

Participant flow — Overall Study
MilestoneBlood Loss and Saline Infusion
Started20
Completed20
Not completed0

Outcome measures

PrimaryCM-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.

Time frame:
Duration of Recovery Period following blood draw (10 minutes)
Reported as:
Mean · Percent change in RI
CM-1600 Ability to Detect Minor Blood Loss
Percent change in RIBlood Loss
CM-1600 Ability to Detect Minor Blood Loss8.0 ± 23.6
PrimaryCM-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.

Time frame:
Recovery period following saline reinfusion (10 minutes)
Reported as:
Mean · Percent change
CM-1600 Ability to Detect Saline Reinfusion
Percent changeSaline Reinfusion
CM-1600 Ability to Detect Saline Reinfusion10.2 ± 38.2

Adverse events

Collected over Adverse events were collected during subject participation in the study and for 24hrs following (e.g., up to 48hrs). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Blood Loss and Saline Infusion0/20 (0%)0/20 (0%)0/20 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Blood Loss and Saline Infusion
Mean39.2 ± 12.2
Sex: Female, Male
Sex: Female, Male(Participants)Blood Loss and Saline Infusion
Female10
Male10
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Blood Loss and Saline Infusion
Region of Enrollment
Region of Enrollment(participants)Blood Loss and Saline Infusion
United States20
08

Study locations

1 site
  • Clinimark
    Louisville, Colorado 80027, United States
09

References and documents

Related links

Study documents

  • Protocol and statistical analysis plan · Jan 12, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05740644
Lead sponsor
Zynex Monitoring Solutions
Responsible party
Sponsor
First posted
Feb 23, 2023
Start date
Feb 13, 2023
Primary completion
Feb 22, 2023
Completion
Feb 22, 2023
Results posted
Jul 16, 2024
Last update
Jul 16, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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