Clinical Evaluation of the CM-1500 During Apheresis Blood... | NCT05012462

NCT05012462

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Apheresis Platelet Donation: CM-1500	Experimental	The subjects will be connected to the CM-1500 during apheresis platelet donation	Device: CM-1500
Apheresis Platelet Donation: CM-1600	Experimental	The subjects will be connected to the CM-1600 during apheresis platelet donation	Device: CM-1600

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CM-1500	Device	The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Characterize Changes in the Relative Index During an Apheresis Procedure	The objective of the study is to characterize changes in the Relative Index (RI) as a representation of its associated parameters during apheresis. This was measured by averaging the RI values after the procedure. Changes in parameters from their baseline can be used as an indicator of potential change in fluid status. This change may be reflected in the RI since it is a summated value (weighted summation of percent change) combining the changes of the parameters into a single value. In the case of fluid loss such as apheresis the RI value may decrease as a result of changes in the parameters which can change in response to fluid status change. The RI is a unitless value with no set min. or max. Within the context of this trial trying to evaluate the RI, a decrease from 100 was considered a good outcome. However, in clinical use, the RI should not be used as an indicator of patient status, instead it could be used to monitor trending of patient parameters relative to their baseline.	Duration of apheresis procedure (e.g., 2 - 3hrs)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Samantha Mack, MD	Vitalant Blood Donation	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Vitalant Blood Donation		Denver	Colorado	80230	United States

Label	URL
Related Info	View source

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	Apheresis Platelet Donation: CM-1500	The subjects will be connected to the CM-1500 during apheresis platelet donation CM-1500: The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value.
FG001	Apheresis Platelet Donation: CM-1600	The subjects will be connected to the CM-1600 during apheresis platelet donation CM-1600: The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors Bioelectrical Impedance, Photoplethysmography (PPG) Amplitude, ECG Amplitude and Skin Temperature. A combination of these parameters is represented by a single number known as the Relative Index value.

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Apheresis Platelet Donation: CM-1500	The subjects will be connected to the CM-1500 during apheresis platelet donation CM-1500: The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value.

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type	Title	Description	Population Description	Reporting Status	Anticipated Posting Date	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Time Frame	Units Analyzed	Denominator Units Selected	Arm/Group Information	Denominators	Classes	Analyses
Primary	Characterize Changes in the Relative Index During an Apheresis Procedure	The objective of the study is to characterize changes in the Relative Index (RI) as a representation of its associated parameters during apheresis. This was measured by averaging the RI values after the procedure. Changes in parameters from their baseline can be used as an indicator of potential change in fluid status. This change may be reflected in the RI since it is a summated value (weighted summation of percent change) combining the changes of the parameters into a single value. In the case of fluid loss such as apheresis the RI value may decrease as a result of changes in the parameters which can change in response to fluid status change. The RI is a unitless value with no set min. or max. Within the context of this trial trying to evaluate the RI, a decrease from 100 was considered a good outcome. However, in clinical use, the RI should not be used as an indicator of patient status, instead it could be used to monitor trending of patient parameters relative to their baseline.	4 subjects were withdrawn from the CM-1500 Arm, and 3 subjects were withdrawn from the CM-1600 Arm	Posted		Mean	Standard Deviation	Relative Index		Duration of apheresis procedure (e.g., 2 - 3hrs)

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Apheresis Platelet Donation: CM-1500	The subjects will be connected to the CM-1500 during apheresis platelet donation CM-1500: The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value.

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Skin Irritation	Skin and subcutaneous tissue disorders		Non-systematic Assessment	Minor skin irritation due to adhesive backing on electrodes

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
ZMS Clinical	Zynex Monitoring Solutions	800-495-6670		clinical@zynexmonitoring.com

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Feb 28, 2022	Jun 20, 2024	Prot_SAP_000.pdf

ID	Title	Description
OG000	Apheresis Platelet Donation: CM-1500	The subjects will be connected to the CM-1500 during apheresis platelet donation CM-1500: The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value.
OG001	Apheresis Platelet Donation: CM-1600	The subjects will be connected to the CM-1600 during apheresis platelet donation CM-1600: The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors Bioelectrical Impedance, Photoplethysmography (PPG) Amplitude, ECG Amplitude and Skin Temperature. A combination of these parameters is represented by a single number known as the Relative Index value.