Work performed and main achievements
During the reporting period, the project moved from pre-clinical validation to first‑in‑human, office‑based use of the Multi4 instrument for bladder cancer interventions. Building on an already validated prototype, we executed a prospective feasibility study to evaluate safety, feasibility, and performance of the four integrated functions (local anaesthesia, tissue excision, enclosed tissue transport, and targeted coagulation) in an outpatient setting.
Clinical feasibility study
We conducted a single‑centre, first‑in‑human feasibility study involving 17 patients undergoing outpatient cystoscopic intervention with the Multi4 instrument under local anaesthesia.
Procedures were completed in the outpatient clinic using standard cystoscopes; no modifications to existing endoscopic platforms were required.
The device’s four functions were performed as intended, enabling anaesthesia delivery, precision tissue removal, secure specimen retrieval through the instrument, and effective coagulation of the tumour bed within the same session.
Overall, the study showed a favourable safety and tolerability profile consistent with awake, office‑based care and no unexpected safety signals.
Tissue samples were adequate for histopathological assessment, supporting the clinical workflow for diagnosis and management.
Procedural times were compatible with an outpatient pathway, aligning with the project’s goal of a ~20‑minute office procedure.
Technical and scientific achievements
First demonstration of a miniaturised, four‑in‑one instrument enabling effective bladder tumour management in awake patients in an outpatient environment.
Confirmation of compatibility with commonly used cystoscopes, lowering barriers to adoption and supporting integration into existing urology clinic workflows.
Clinical‑grade performance of the device’s core functions (cutting, specimen transport, and haemostasis) under real‑world procedural conditions.
Generation of a clinical dataset that supports the regulatory pathway and informs the design of subsequent, larger prospective studies focused on recurrence and health‑economic outcomes.
Scientific outputs
Interim findings have been peer‑reviewed as an abstract and presented at the American Urological Association (AUA) Annual Meeting in Las Vegas.
Manuscripts detailing the clinical feasibility outcomes and technical performance are in preparation for submission to peer‑reviewed journals.
Collectively, the work performed confirms the feasibility of shifting a significant portion of bladder cancer interventions from operating theatres to the outpatient clinic, while maintaining procedural quality and patient tolerability. The results provide a solid foundation for further clinical evaluation and wider clinical adoption.
