Two single arm, multicentre unblinded first-in-human trials, including 2 phases and a qualitative substudy investigating a novel ureteric stent in Kidney stone patients and Oncology patients to determine the reduction of encrustation, biofilm deposition and complications compared to a conventional JJ stent (CASSETTE)

BACKGROUND The urinary system is complex and difficult to repair. Many factors can affect urine drainage, resulting in inability to urinate, pain, and kidney damage. Stents and catheters are tubular devices that are used as temporary solutions to maintain urine drainage while exploring patient-specific long-term treatments. These devices are prone to blockage due to the build-up of crystals and bacterial deposits (encrustation-and-biofilm-formation (E&B)), causing infection. Infections associated with stents and catheters impose a £2.5b annual burden on the NHS? they require antibiotics and possibly surgery under general anesthetic, with negative effects on patients’ health and increased demand for clinical services. AIMS We have identified a reason behind failure of these devices and have developed new patented stents preventing blockage by crystals and bacterial build-up. To date, we have conducted laboratory experiments (to show bench top performance) and pre-calinical testing (to show the safety against live tissue), and aim to perform our first in human trials to assess wether this technology is not worst than existing technologies in the market (by depetermining the rates of stent failure, primary objective) and to assess extent of ecrustation and biofilm formation (by conducting aboratory analyis and qualitative interviews, secondary objective).