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| Name | Class |
|---|---|
| Singapore General Hospital | OTHER |
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The goal of this late feasibility clinical trial is to evaluate the safety and effectiveness of the Automated Wearable Artificial Kidney (AWAK) peritoneal dialysis (PD) device in subjects with end-stage kidney disease. The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AWAK PD | Experimental | Wearable/Ultra-portable peritoneal dialysis device for home-use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AWAK PD | Device | Daily 7- or 9-hour therapy (with or without a last fill) that is a form of automated peritoneal dialysis being done by subjects who are already on daily PD therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of completed therapies | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects maintaining body weight within ±5% of the subject's target weight | 7 days | |
| Change in serum levels of markers of uremia (urea and creatinine) | 7 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marjorie Foo | Singapore General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore General Hospital | Singapore | Singapore |
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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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| Proportion of subjects maintaining serum sodium and potassium levels within normal clinical ranges |
| 7 days |
| Incidence of serious adverse events (SAEs), serious adverse device effects (SADEs), adverse events (AEs), adverse device effects (ADEs), and device deficiency events | 7 days |
| Incidence of peritonitis related to the use of AWAK PD | 30 days |
| Change in the incidence and severity of dialysis-related signs and symptoms based on responses on the PD Dialysis Symptoms Questionnaire | 30 days |
| 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 |