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