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The study is a prospective, non-randomized, non-blinded, non-significant risk, multi-center study enrolling up to 500 healthy adult subjects consented to undergo a whole blood donation procedure. The study will involve enrolling subjects that will undergo blood donation wearing the study device (CM-1600 Device) and capture study-required physiological parameters pre-, during, and post-donation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blood Loss | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM-1600 | Device | Subjects undergoing blood donation will be connected to the CM-1600 device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL) | 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. | Recovery period following donation (10 minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vitalant Research Institute | Denver | Colorado | 80230 | United States | ||
| SunCoast Blood Centers |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Blood Loss | CM-1600: Subjects undergoing blood donation will be connected to the CM-1600 device. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Blood Loss | CM-1600: Subjects undergoing blood donation will be connected to the CM-1600 device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in the Relative Index (RI) After Minor Blood Loss (e.g., 500mL) | 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. | 18 subjects were unevaluable; 19 subjects were withdrawn | Posted | Mean | Standard Deviation | Percent change in RI | Recovery period following donation (10 minutes) |
|
Adverse Events were recorded during subject participation and for 24hrs after participation was complete, a total of up to 27hrs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Blood Loss | CM-1600: Subjects undergoing blood donation will be connected to the CM-1600 device. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Light-headedness due to blood donation procedure | General disorders | Non-systematic Assessment | Subject experienced light-headedness accompanied with nausea or dizziness in response to the blood donation procedure. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| ZMS Clinical | Zynex Monitoring Solutions | 800-495-6670 | clinical@zynexmonitoring.com |
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| 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 | Nov 16, 2022 | Jun 20, 2024 | Prot_SAP_000.pdf |
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| Bradenton |
| Florida |
| 34211 |
| United States |
| ClinCept, LLC | Columbus | Georgia | 31904 | United States |
| Blood Assurance | Chattanooga | Tennessee | 37403 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 | Blood Loss | CM-1600: Subjects undergoing blood donation will be connected to the CM-1600 device. |
|
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| 0 |
| 351 |
| 0 |
| 351 |
| 4 |
| 351 |
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