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

Not Applicable

• Conditions: Chronic Kidney Disease Stage V
• Interventions: Device: Inteligent Dialysis Assistant (IDA)

• Registration Number: NCT05342935
• Lead Sponsor: liberDi Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study First Submitted: 2022-04-18
• Study First Submitted QC: 2022-04-18
• Last Update Submitted: 2022-04-18
• Study First Posted: 2022-04-25
• Last Update Posted: 2022-04-25
• Study Start: 2022-06
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Male and female subjects with CKD stage 5 under peritoneal dialysis
• Age ≥18 years
• Mental ability to understand the study procedures and provide informed consent
• At least 3 months on peritoneal dialysis prior to enrollment
• At least 3 daily exchanges
• Stable PD prescription for the last 2 months
• Subject who is self-treated

Exclusion Criteria

• Need of cycler (APD)
• Known Mechanical problem during the last month (i.e. drainage or fill problems)
• Pregnant or breastfeeding women, and women with childbearing potential who is unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the entire clinical trial period.
• Subjects who are unwilling or unable to comply with study procedures
• Known Peritonitis or other catheter related infection during the last 3 months prior to enrollment
• Known Congestive Heart Failure stage III-IV
• Any history of kidney malignancy
• Any planned hospitalization for elective Procedure(s)throughout the duration of participation in the study
• Non-elective hospitalization in the last 3 months prior to enrollment
• Any other medical or mental condition, that at the investigator's discretion may prevent the subject from participating in the study
• Participation in any other clinical study within 4 weeks prior to enrollment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IDA treatment	Inteligent Dialysis Assistant (IDA)	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.

Primary Outcome Measures

Name	Time	Method
Safety Endpoint - Serious Adverse Events Rate	42 days	The safety of the IDA, as determined by the accumulative incidence of device-related SAEs throughout the 14-day prospective study period

Secondary Outcome Measures

Name	Time	Method
IDA Usability by Investigator	14 days	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
IDA Feasibility	14 days	The feasibility of the treatment will be evaluated by recording time length of the in/out PD exchange procedure
IDA Usability by Subject	14 days	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.