Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical pilot study is to evaluate the ability of the device to properly detect the hydration status of the subject through the study of fluid removal data during dialysis and HemoCept device data.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between HemoCept device and changes in dry weight. | The primary end point will be to determine if there is a correlation between HemoCept device data and dry weight changes during dialysis. The primary analysis will be conducted at specific points during dialysis treatment: prior to dialysis, in the middle of the dialysis session, and immediately following the completion of dialysis treatment. | At specified points during dialysis treatment for 9 dialysis sessions, over the course of 3 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Device-related adverse events: device-related adverse events included all adverse events classified as definitely, probably, possibly, or undetermined relation to the device or procedure | All secondary endpoints will be summarized descriptively, and no hypothesis tests are planned. | From enrollment until the completion of 9 dialysis sessions, over a period of 3 weeks. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Subject is pregnant, breast-feeding, or intends to become pregnant during the course of the study.
Subject has a personal medical history that includes:
Subject has had a heart transplant.
Not provided
Not provided
Subjects between (and including) the ages of 18 and 75 and who meet all the Inclusion/Exclusion criteria
Not provided
Not provided
| 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
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |