Status:
UNKNOWN
A Prospective, Open-label, Multi-center Pilot Study to Evaluate the Safety, Feasibility and Usability of the IDA
Lead Sponsor:
liberDi Ltd.
Conditions:
Chronic Kidney Disease Stage V
Eligibility:
All Genders
18-120 years
Phase:
NA
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, t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05342935
Start Date
June 1 2022
End Date
March 1 2023
Last Update
April 25 2022
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