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

Chronic Kidney Disease Stage 5 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04808011
• Other study ID #: CSP-028-20
• Status: Recruiting
• Phase: N/A
• Start date: December 22, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: November 2022
• Source: liberDi Ltd.
• Contact: Maya Shick, b.sc
• Phone: 972523313350
• Email: Hila[@]liberdi.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2023
• Est. primary completion date: December 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Subjects with CKD stage 5 treated by continuous ambulatory peritoneal dialysis (CAPD)
• Male or female, Age >18 years
• Mental ability to understand study procedures and provide an informed consent
• More than 3 months on PD (Peritoneal Dialysis)
• At least 3 daily exchanges
• Self-treated subject
• Stable PD prescription for the last month

Exclusion Criteria:

• Need of cycler (APD, Automated Peritoneal Dialysis)
• Known mechanical problem (drainage, fill) during the last month prior to enrollment
• Pregnant or breastfeeding women
• subject who is unwilling or unable to comply with study procedures
• Known Peritonitis or other catheter associated infections during the last 3 months prior to enrollment
• Known Congestive heart failure stage III- IV
• Non-elective hospitalization during 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

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 5
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Be'er Sheva
Israel	Carmel MC	Haifa
Israel	Meir Medical Center	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
liberDi Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Device-Related Serious Adverse Event Incidence	Incidence of device-related SAEs throughout the active investigational phase (14 days).	14 days
Primary	AE during on site exchange	Incidence of device-related adverse events during the on-site exchange - phase I of the study.	1 day
Secondary	Procedure Time Length	Time length of the in/out PD exchange procedure.	14 days
Secondary	Usability Questionnaire	completion of a Usability questionnaire, designed by the Sponsor, which reflects the physician's impression by the device usage. The questionnaire consists of 4 questions devided to "yes/no" sub-questions.	14 days
Secondary	Device-Related Serious Adverse Events Incidence During Follow Up Period	Incidence of device-related SAEs during the additional 14-day follow up period	14 days
Secondary	Renal Treatment Internal Questionnaire	Analysis of the subject's treatment feedback and effect on quality of life, provided to him/her by using the device. The questionnaire consists of 6 questions ranked from 1 (very dissatisfied) to 5 (very satisfied). The Total Score will be calculated for this questionnaire, with a range of 6-30. A score above 18 will be considered "satisfied".	42 days