A Prospective, Open-label, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA (CSP-027-21)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Kidney Disease Stage V
• Intervention / Treatment: Device: Inteligent Dialysis Assistant (IDA)

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maya Shick; Phone Number: 97248228090; Email: maya@liberdi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IDA treatment; 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: liberDi Ltd.
• Investigators: Principal Investigator: Richard Corbett, MD, Imperial College Medical Center

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: April 18, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: liberDi

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No