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| Name | Class |
|---|---|
| DTarget | UNKNOWN |
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Non-invasive monitoring to measure changes in blood volume.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no blood draw | Sham Comparator | CM 1500 with no blood draw |
|
| blood draw | Active Comparator | CM 1500 with blood draw |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CM 1500 | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw | Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw | At study completion (completion of blood draw) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Ziegler, MD | Premier Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Premier Research Group | Salt Lake City | Utah | 84107 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | no Blood Draw | CM 1500 with no blood draw CM 1500 |
| FG001 | Blood Draw | CM 1500 with blood draw CM 1500 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | no Blood Draw | CM 1500 with no blood draw CM 1500 |
| BG001 | Blood Draw | CM 1500 with blood draw CM 1500 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Detect by Non-invasive Monitoring a Change in Blood Volume During a Whole Blood Draw | Detection by non-invasive monitoring a change in blood volume (yes or no) during a whole blood draw | Number of subjects for which blood loss was detected. | Posted | Number | participants | At study completion (completion of blood draw) |
|
Adverse event data was collected through the completion of the study. Adverse events per subject may have occurred during the blood draw or within 24 hours following with any potential reaction to electrode adhesive.
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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 | no Blood Draw | CM 1500 with no blood draw CM 1500 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasovagal Reaction to Blood Draw | General disorders | Non-systematic Assessment | Several subjects had a vasovagal reaction to the blood draw. Specifically, subject reported being lightheaded or dizzy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Donald Gregg | Zynex Monitoring Solutions | 1-800-495-6670 | dgregg@zynex.com |
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| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Height | Mean | Full Range | inches |
|
| Weight | Mean | Full Range | pounds |
|
| Units | Counts |
|---|
| Participants |
|
|
| 5 |
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Blood Draw | CM 1500 with blood draw CM 1500 | 0 | 45 | 0 | 45 | 5 | 45 |
|
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