Periodic Reporting for period 1 - Multi4 (Multi4 - the first surgical instrument for bladder cancer treatment through a 20-minute outpatient procedure)
Período documentado: 2024-09-01 hasta 2025-08-31
Bladder cancer is one of the most common cancers and the most expensive to manage. Despite this burden, clinical practice have changed little since the 1960s. The standard of care—tumour removal in an OR under anaesthesia—is resource‑intensive, requires highly specialised skills, and carries risks. Patients often need repeated procedures because of high risk of recurrences. This strains healthcare capacity, prolongs waiting times and drives costs, while negatively affecting patient experience and equity of access. We addresse this gap by developing a surgical instrument that enables safe, effective bladder tumour removal as an quick 20‑minute outpatient procedure on awake patients.
Overall objectives and pathway to impact:
Demonstrate safety, feasibility and patient tolerability of office‑based tumour removal on awake patients in a first‑in‑human clinical study cleared by a national competent authority.
Generate a robust clinical evidence package to support CE marking, industrialise and prepare for market introduction.
If successful, Multi4 will enable a shift of a significant share of bladder cancer interventions from operating theatres to urology clinics. This can shorten time‑to‑treatment, reduce dependence on anaesthesia and scarce theatre capacity, lower complication risks, and improve patient experience.
Overall objectives and pathway to impact:
Demonstrate safety, feasibility and patient tolerability of office‑based tumour removal on awake patients in a first‑in‑human clinical study cleared by a national competent authority.
Generate a robust clinical evidence package to support CE marking, industrialise and prepare for market introduction.
If successful, Multi4 will enable a shift of a significant share of bladder cancer interventions from operating theatres to urology clinics. This can shorten time‑to‑treatment, reduce dependence on anaesthesia and scarce theatre capacity, lower complication risks, and improve patient experience.
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.
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.
Overview of results to date
The project has delivered the first clinical demonstration of a miniaturised, four‑in‑one instrument that enables definitive outpatient management of selected bladder lesions in awake patients. In a first‑in‑human feasibility study (17 patients), all four integrated functions—local anaesthesia delivery, precision excision, enclosed tissue transport, and targeted coagulation—were performed as intended in a urology clinic using standard cystoscopes.
The procedure was feasible and well tolerated in an office‑based setting, with no unexpected safety signals. Tissue specimens were adequate for histopathology, supporting diagnostic decision‑making within the same care pathway.
These findings validate the transition from pre‑clinical testing to clinical use and provide a foundation for CE marking and subsequent larger prospective studies focused on recurrence and health‑economic outcomes.
Beyond the state of the art: technical and clinical advances
Integrated four‑step intervention in a single micro‑instrument: Multi4 combines anaesthesia, excision, secure specimen retrieval, and haemostasis, reducing instrument exchanges and enabling a streamlined, single‑visit procedure.
Enclosed tissue transport: The device retrieves specimens through the instrument, aiming to minimise intra‑bladder dispersion and the theoretical risk of tumour cell re‑seeding while preserving specimen integrity for pathology.
Outpatient, awake procedure: Demonstrates the feasibility of shifting selected bladder cancer interventions from operating theatres to the clinic, potentially reducing the need for general anaesthesia and theatre resources.
Procedural reliability: Clinical‑grade performance of cutting, transport and coagulation functions under real‑world conditions, supporting standardisation of a reproducible office‑based technique.
Indicative potential impacts
Patient-level: Faster access to treatment; improved experience and recovery without general anaesthesia; high‑quality biopsy and targeted treatment in a single visit.
Clinician-level: Simplified, repeatable workflow that can be performed in the clinic; improved specimen quality and margin control due to immediate coagulation.
Health‑system-level: Potential to relieve operating theatre bottlenecks, shorten waiting lists, and reduce procedure‑related complications and costs associated with recurrent interventions and surveillance.
Public health and sustainability: Supports more equitable access across regions by leveraging existing cystoscope infrastructure; potential reductions in resource use and environmental footprint by shifting out of the operating theatre.
Platform potential: The core design is adaptable to other hard‑to‑reach organs, opening avenues for same‑session diagnosis and treatment beyond bladder cancer.
The project has delivered the first clinical demonstration of a miniaturised, four‑in‑one instrument that enables definitive outpatient management of selected bladder lesions in awake patients. In a first‑in‑human feasibility study (17 patients), all four integrated functions—local anaesthesia delivery, precision excision, enclosed tissue transport, and targeted coagulation—were performed as intended in a urology clinic using standard cystoscopes.
The procedure was feasible and well tolerated in an office‑based setting, with no unexpected safety signals. Tissue specimens were adequate for histopathology, supporting diagnostic decision‑making within the same care pathway.
These findings validate the transition from pre‑clinical testing to clinical use and provide a foundation for CE marking and subsequent larger prospective studies focused on recurrence and health‑economic outcomes.
Beyond the state of the art: technical and clinical advances
Integrated four‑step intervention in a single micro‑instrument: Multi4 combines anaesthesia, excision, secure specimen retrieval, and haemostasis, reducing instrument exchanges and enabling a streamlined, single‑visit procedure.
Enclosed tissue transport: The device retrieves specimens through the instrument, aiming to minimise intra‑bladder dispersion and the theoretical risk of tumour cell re‑seeding while preserving specimen integrity for pathology.
Outpatient, awake procedure: Demonstrates the feasibility of shifting selected bladder cancer interventions from operating theatres to the clinic, potentially reducing the need for general anaesthesia and theatre resources.
Procedural reliability: Clinical‑grade performance of cutting, transport and coagulation functions under real‑world conditions, supporting standardisation of a reproducible office‑based technique.
Indicative potential impacts
Patient-level: Faster access to treatment; improved experience and recovery without general anaesthesia; high‑quality biopsy and targeted treatment in a single visit.
Clinician-level: Simplified, repeatable workflow that can be performed in the clinic; improved specimen quality and margin control due to immediate coagulation.
Health‑system-level: Potential to relieve operating theatre bottlenecks, shorten waiting lists, and reduce procedure‑related complications and costs associated with recurrent interventions and surveillance.
Public health and sustainability: Supports more equitable access across regions by leveraging existing cystoscope infrastructure; potential reductions in resource use and environmental footprint by shifting out of the operating theatre.
Platform potential: The core design is adaptable to other hard‑to‑reach organs, opening avenues for same‑session diagnosis and treatment beyond bladder cancer.