NCT04808011

A Single Arm, Multi-Center Study To Evaluate The Intelligent Dialysis Assistant (IDA)

A Single Arm, Prospective, Open Label, Cross-Over, Multi-Center Study to Evaluate the Safety, Feasability and Usability of the Intelligent Dialysis Assistant (IDA)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: liberDi Ltd. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This is a multi-center, open label, cross-over clinical study. A total of 18 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: 1. 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. 2. Second period (Interventional): 14-day interventional period, where subjects will perform dialysis exchanges using the IDA according to the below visit schedule. 3. 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.

Detailed description

This is a multi-center, open label, cross-over clinical study. A total of 20 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 two cohorts and two phases: in the first phase (phase I), 20 subjects will be recruited as Cohort 1 to undergo a single exchange in the medical center using the IDA. Following the completion of recruitment of all 20 subjects and the performance of the single on site exchange, the Sponsor will perform an interim analysis of the results for safety and initial feasibility, followed by submission of the results to the MoH and approval of the second phase (phase II). The expected timeframe between phase I and phase II is up to 4 weeks. An additional cohort, Cohort 2, will be added to Phase I, which will include additional ten (10) subjects. These subjects will undergo the same procedure at the dialysis clinic, with the addition of blood sampling for CBC and Chemistry two (2) hours ±30 minutes after the procedure. A total of 20 subjects from either cohort, meeting the inclusion and exclusion criteria of Cohort 1, will continue to complete the second phase of the study (Phase II). Phase II of 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.

Conditions

• Chronic Kidney Disease Stage 5

Interventions

Type	Name	Description
DEVICE	Intelligent Dialysis Assistant (IDA)	The IDA is intended for home dialysis for subjects who are stage 5 kidney diease patients and who perform Peritoneal Dialysis. The system is used deveral times a day for approximately 20 minutes for each cycle. During the interventional period, subjects will use only the investigational IDA system for their in/out exchanges.

Timeline

• Start date: 2021-12-22
• Primary completion: 2023-12-22
• Completion: 2023-12-30
• First posted: 2021-03-19
• Last updated: 2022-11-15

Locations

3 sites across 1 country: Israel