Trial Outcomes & Findings for Clinical Evaluation of the Zynex Monitoring System, Model CM-1600 (NCT NCT05740644)
NCT ID: NCT05740644
Last Updated: 2024-07-16
Results Overview
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.
COMPLETED
NA
20 participants
Duration of Recovery Period following blood draw (10 minutes)
2024-07-16
Participant Flow
Participant milestones
| Measure |
Blood Loss and Saline Infusion
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.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Blood Loss and Saline Infusion
n=20 Participants
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.
|
|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 12.2 • n=20 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=20 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Blood Loss
n=20 Participants
CM-1600: Healthy subjects undergoing a manual blood loss of up to 500mL while being connected to the CM-1600 device.
|
|---|---|
|
CM-1600 Ability to Detect Minor Blood Loss
|
8.0 Percent change in RI
Standard Deviation 23.6
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Blood Loss
n=20 Participants
CM-1600: Healthy subjects undergoing a manual blood loss of up to 500mL while being connected to the CM-1600 device.
|
|---|---|
|
CM-1600 Ability to Detect Saline Reinfusion
|
10.2 Percent change
Standard Deviation 38.2
|
Adverse Events
Blood Loss and Saline Infusion
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place