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This is a multi-center, open label, cross-over clinical study. A total of 15 subjects will be enrolled to use the IDA for every peritoneal dialysis exchange for 14 days. To participate in the study, the subjects must have current CKD5 and have been treated with PD for at least 3 months. The subjects will undergo a single peritoneal dialysis exchange procedure at the PD clinic, under supervision of the medical staff and instructed about its operation. Further exchanges will be performed by the subjects themselves at home.
The study includes three periods:
First period (Observational): 14-day Observational Period. Eligible subjects who sign informed consent will continue with their regular CAPD treatment while performing measurement and recording of dialysate in/out time.
Second period (Interventional): 14-day interventional period, where subjects will perform dialysis exchanges using the IDA according to the below visit schedule.
Third period (Follow up): 14-day follow up period, during which the study staff will call the subject once weekly to inquire about device-related SAEs and any changes to concomitant medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDA treatment | Experimental | Each subject will be treated with his prescribed manual PD for 14 days, followed by a treatment period of 14 days with the investigational IDA system, and concluding with additional 14 days of treatment with the manual PD. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inteligent Dialysis Assistant (IDA) | Device | The IDA is a small dialysis system that allows a higher level of freedom to the patients, permitting them to perform the PD exchange while continuing to do their everyday activities |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint - Serious Adverse Events Rate | The safety of the IDA, as determined by the accumulative incidence of device-related SAEs throughout the 14-day prospective study period | 42 days |
| Measure | Description | Time Frame |
|---|---|---|
| IDA Usability by Investigator | The usability of the IDA will be evaluated by completing an internal usability questionnaire by the investigator that will check the operation of the various system controls and the ease of use | 14 days |
| IDA Usability by Subject |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maya Shick | Contact | 97248228090 | maya@liberdi.com |
| Name | Affiliation | Role |
|---|---|---|
| Richard Corbett, MD | Imperial College Medical Center | Principal Investigator |
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Subjects will pursue their usual manual PD exchanges, followed by the treatment with the investigational device and then back to their manual PD.
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The completion of the internal Satisfaction and QoL internal questionnaire by each participating subject. Answers in the questionnaire range from 1 (poor) to 5 (excellent), and the results range from 6-30 - the higher the result, the higher the subject's wellbeing. |
| 14 days |
| IDA Feasibility | The feasibility of the treatment will be evaluated by recording time length of the in/out PD exchange procedure | 14 days |