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Prospective, multicenter, single arm, post-market study to evaluate real world clinical outcomes in ESRD patients receiving in-home dialysis on the Tablo Hemodialysis System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tablo Hemodialysis System | Home dialysis treatment with the Tablo Hemodialysis System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tablo Hemodialysis System | Device | Home hemodialysis treatments ~4 times a week. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Weekly Standardized Dialysis Adequacy | Weekly standardized dialysis adequacy (stdKt/V) measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. stdKt/V values of ≥ 2.1 are regarded as being adequate. | 12-months |
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| Measure | Description | Time Frame |
|---|---|---|
| Health Outcomes | Change in health outcomes from baseline to 12-months, as measured by the 12-item Short Form Health Survey (SF-12) Questionnaire. The questionnaire consists of 12 items weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100. Higher scores mean a better outcome. | Change from Baseline at 12-months |
Inclusion Criteria:
Exclusion Criteria:
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Patients with end stage renal disease (ESRD) who are on, or planning to be on, maintenance hemodialysis.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Josh Schumacher | Contact | (669) 231-8200 | ClinicalTeam@outsetmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Satellite Healthcare, Inc. | Recruiting | San Jose | California | 95128 | United States |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| Sleep Outcomes | Change in sleep from baseline to 12-months, as measured by the Insomnia Severity Index (ISI). The minimum and maximum values are 0 and 28 scores, respectively. Higher scores mean a worse outcome. | Change from Baseline at 12-months |
| Care Partner Burden | Change in care partner burden from baseline to 12-months, as measured by the Zarit Burden Interview-12 (ZBI-12) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating a worse outcome. | Change from Baseline at 12-months |
| Desert Cities Dialysis | Completed | Victorville | California | 92395 | United States |
| Berkshire Medical Center | Recruiting | Pittsfield | Massachusetts | 01201 | United States |
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| St. Peter's Health | Recruiting | Helena | Montana | 59601 | United States |
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| Dialysis Center of Lincoln | Recruiting | Lincoln | Nebraska | 68512 | United States |
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| Parker Jewish Institute | Recruiting | New Hyde Park | New York | 11040 | United States |
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| NYU Grossman School of Medicine | Recruiting | New York | New York | 10016 | United States |
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| Rogosin Institute | Recruiting | New York | New York | 10021 | United States |
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| USRC Kidney Research | Recruiting | Plano | Texas | 75024 | United States |
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| University of Virginia | Withdrawn | Staunton | Virginia | 24401 | United States |
| D052776 |
| Female Urogenital Diseases |
| 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 |