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

Primary Purpose

Chronic Kidney Disease Stage V

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Inteligent Dialysis Assistant (IDA)
Sponsored by
liberDi Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Kidney Disease Stage V

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    IDA treatment

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    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.
    IDA Feasibility
    The feasibility of the treatment will be evaluated by recording time length of the in/out PD exchange procedure

    Full Information

    First Posted
    April 18, 2022
    Last Updated
    April 18, 2022
    Sponsor
    liberDi Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05342935
    Brief Title
    A Prospective, Open-label, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA
    Acronym
    CSP-027-21
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 2022 (Anticipated)
    Primary Completion Date
    December 2022 (Anticipated)
    Study Completion Date
    March 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    liberDi Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Disease Stage V

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Subjects will pursue their usual manual PD exchanges, followed by the treatment with the investigational device and then back to their manual PD.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    15 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    IDA treatment
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    Inteligent Dialysis Assistant (IDA)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Safety Endpoint - Serious Adverse Events Rate
    Description
    The safety of the IDA, as determined by the accumulative incidence of device-related SAEs throughout the 14-day prospective study period
    Time Frame
    42 days
    Secondary Outcome Measure Information:
    Title
    IDA Usability by Investigator
    Description
    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
    Time Frame
    14 days
    Title
    IDA Usability by Subject
    Description
    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.
    Time Frame
    14 days
    Title
    IDA Feasibility
    Description
    The feasibility of the treatment will be evaluated by recording time length of the in/out PD exchange procedure
    Time Frame
    14 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    120 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maya Shick
    Phone
    97248228090
    Email
    maya@liberdi.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard Corbett, MD
    Organizational Affiliation
    Imperial College Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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