Can novel ureteric stents offer a better patient outcome compared to existing standard ureteric stents (CASSETTE)

Research Question: Does a novel ureteric stent design, used as a direct substitute for existing devices, lead to reduced encrustation compared to a conventional stent?

Background: Since 2015, our team has investigated the mechanisms behind stent Encrustation-and-Biofilm-Formation (E&B), leading to early removal/replacement.

We identified key fluid metrics governing E&B, allowing us to introduce a specialised stent design that increases the force over area on the stent surface leading to a cleaner surface. This was demonstrated in computational-fluid-dynamic (CFD) models and validated experimentally. Then, a prototype was developed and successfully tested in pre-clinical models.

In the context of the IDEAL-D [1] variant for medical devices, we have completed stage-0 and demonstrated: Safety in pigs. Reduction in E&B.

We believe the device is ready for First-in-Human testing, thus are moving to IDEAL stage-1 to gather evidence for obtaining a CE/UKCA-mark through a notified body. Aims and Objectives: Product development and regulatory approvals. Completing pilot manufacturing. Completing Technical-Documentation to the MDR2017/745.

Obtaining MHRA No Objection approval for human trial.

Validating the controlled manufacture and sterilisation process (including selection of suitable packaging materials) conforming to ISO13485:2016. Installing ISO13485:2016 into Sooba-Medical. Developing design dossier for review by a Notified-Body as part of CE/UKCA-mark application process. IP development.

The priority patent for this technology (“Stent with Streamlined Side Holes”), which includes the stent design and manufacturing process, was filed in 2017 in the UK by the University-of-Southampton (UoS). This was followed by a PCT-International application (WO2019/048860) that was submitted in 2018.

Currently, there are patent applications pending in the US and Europe. Market assessment, business case and commercial strategy.

A detailed market assessment will include the choice of region, market size, timeline, cost comparison to competition, price strategy, market penetration. Establishing Sooba-Medical as the commercial vehicle. IP position and relationship with UoS. Determine cost of manufacturing, sales, and marketing.

Preliminary health economic assessment, involving Wessex AHSN.

Milestones and deliverables: Year 1: Finalised, sterilised and packaged prototype for testing MHRA No objection letter in place Patent landscape mapped STOP/GO MILESTONE – MHRA approval, trial protocol and the appropriate ethics in place?

Year 2: Recruiting trial candidates at two NHS trusts UHS – stone patients UCLH – cancer patients Market assessment: business plan, applicability STOP/GO MILESTONE – sufficient recruitments are in place? A robust business plan developed? UHS trial started?

Year 3: Finishing UHS and UCLH trials Installing ISO13485:2016 into Sooba-Medical Application for UKCA/CE-mark FINAL MILESTONE – have a safe, clinically acceptable, and commercially viable product ready for analysis and development of wider trials, including demonstration of proof-of-concept to support a future proposal for an EME-funded efficacy study.

Anticipated Impact and Dissemination: Findings will inform final development of the product, manufacturing scale-up, submission for regulatory approval, early marketing, and design of larger studies to demonstrate impact for patients and the NHS.

Dissemination of findings will be through academic routes via a protocol paper, main clinical results paper and an economic paper. Participants will also receive the study results.