Status:
UNKNOWN
A Single Arm, Multi-Center Study To Evaluate The Intelligent Dialysis Assistant (IDA)
Lead Sponsor:
liberDi Ltd.
Conditions:
Chronic Kidney Disease Stage 5
Eligibility:
All Genders
18-90 years
Phase:
NA
Brief 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, t...
Detailed 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, t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04808011
Start Date
December 22 2021
End Date
December 30 2023
Last Update
November 15 2022
Active Locations (3)
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1
Soroka Medical Center
Beersheba, Israel
2
Carmel MC
Haifa, Israel
3
Meir Medical Center
Kfar Saba, Israel