IDA
Research type
Research Study
Full title
A PROSPECTIVE, OPEN LABEL, CROSS-OVER, MULTI-CENTER PILOT STUDY TO EVALUATE THE SAFETY, FEASIBILITY AND USABILITY OF THE INTELLIGENT DIALYSIS ASSISTANT (IDA) IN SUBJECTS WITH CHRONIC KIDNEY DISEASE STAGE V TREATED WITH PERITONEAL DIALYSIS
IRAS ID
299927
Contact name
Richard Corbett
Contact email
Sponsor organisation
liberDi Ltd.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
This is a research study with the Intelligent Dialysis Assistant (IDA). IDA is a medical device developed by liberDi for patients suffering from Chronic Kidney Disease Stage V (CKD5) requiring peritoneal dialysis (PD). This device allows patients to perform the necessary treatment while continuing their everyday activities like being it in their own home. Changing the treatment environment from a healthcare facility to home care, may contribute dramatically to the patient quality of life.
The study is multi-center, open label, cross-over pilot clinical study. A maximum of 15 subjects will be enrolled to use the IDA for every PD 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. Each subject will participate in the study for a duration of 42 days. The total expected study duration is approximately 8 months.REC name
London - Stanmore Research Ethics Committee
REC reference
22/LO/0149
Date of REC Opinion
6 Apr 2022
REC opinion
Further Information Favourable Opinion