NCT05342935

A Prospective, Open-label, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA

A Prospective, Open-label, Cross-over, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA in Subjects Suffering From a Stage 5 Kidney Disease and Who Are Treated With Peritoneal Dialysis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: liberDi Ltd. · Industry
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Kidney Disease Stage V

Interventions

Type	Name	Description
DEVICE	Inteligent Dialysis Assistant (IDA)	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

Timeline

• Start date: 2022-06-01
• Primary completion: 2022-12-01
• Completion: 2023-03-01
• First posted: 2022-04-25
• Last updated: 2022-04-25