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The pilot clinical study will assess the correlation between fluid removal during dialysis and HemoCept device data.
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| Measure | Description | Time Frame |
|---|---|---|
| Correlation between dry weight changes and HemoCept device measurements. | The primary analysis will be conducted using HemoCept device readings taken before dialysis and at the end of dialysis, just prior to return of blood and fluid from the machine. The device data will then be assessed for its comparison to dry weight changes. | Before and after one dialysis session, over the course of 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Device related adverse events, and the possible correlation of skin tone to device results. | -Device-related adverse events: device-related adverse events included all adverse eventsclassified as definitely, probably, possibly, or undetermined relation to the device or procedure --Exploratory correlation of skin tone and device performance: Monk Skin Tone data will be collected to explore potential correlation between subject skin tone and HemoCept device readings. |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects between (and including) the ages of 18 and 75 and who meet all the Inclusion/Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Jusmin Patel, MD | Sierra Nevada Specialty Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sierra Nevad Specialty Care | Reno | Nevada | 89511 | United States |
There is not a plan to make IPD available
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Before and after 1 dialysis session, over the course of 1 day. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |