Clinical Validation

iRen has successfully proven feasibility and safety

The first-in-human open single arm, multi-center clinical trial was performed at two separated PD units in Israel.

The first-in-human open single arm, multi-center clinical trial was performed at two separated PD units in Israel. Ten (10) patients (two (2) women and eight (8) men) participated in this study

The iRen Digital Dialysis Clinic is a newly developed, portable automatic system for Peritoneal Dialysis (PD) exchanges.

Over the past decades, multiple attempts have been made to improve PD outcomes. The iRen iDA was designed to simplify and accelerate the connection process. The iRen iDA was also designed to reduce infection risk by allowing local sterilization of the connection tip within the machine before PD exchange starts.

The study results ratifies that iRen’s Digital Dialysis Clinic is safe to use and feasible for a single automatic PD exchange.

iRen presented these study results as a poster at the ASN Kidney WK, WDC, USA 2019 and as a publication in the PDI – Peritoneal Dialysis International.

View publication

iRen also performed a human factor validation study evaluating all user groups:

people requiring dialysis & their caregivers and healthcare professionals such as nephrologists and dialysis nurses. The study simulated a real world environment and demonstrated that effective training can be done in as little as 90 minutes and that iRen’s Digital Dialysis Clinic can easily be operated by anyone.