CLARISURGE · Advancing Mountable Endoscopic Cap for Precision Oesophageal Mucosal Resurfacing with Non-Thermal Ablation

Treatments that minimize adverse effects on deep tissues may be critical for successful therapy in a superficial pre-cancerous condition such as Barrett's oesophagus. Although endoscopic therapeutic interventions efficiently eradicate superficial abnormal tissues in the oesophagus, the main challenge with their current deployments is that the therapy depth typically has a more profound thermal injury than the target layer. The project's objective is to develop a novel endoscopic cap that provides local non-thermal ablation to the superficial layers of the target oesophageal wall with sufficient depth for mucosal resurfacing. A design compatible with endoscopes will enable navigation, diagnosis, and ablation together—all-in-one.In support of the objective, the research programme is split into the following indicative specific aims based on EU MDR (2017/745) ISO (13485) & TSE (60601) regulations. Aim-1: Development of numerical modelling to mimic non-thermal ablation dynamics of the endo-cap. Aim-2: Optimization of numerical modelling with computational accuracy by in-vitro studies. Aim-3: Establishing the quality control process. Aim-4: Configuration of the endo-cap's original design in a CAD program and then realize the design with an optically transparent material containing electrodes for a porcine animal model, in vivo. Aim-5: Integration of the endo-cap with an endoscopy system to construct an endoscope equipped with the endo-cap for preclinical trials. Aim-6: Investigating the functional feasibility of an endoscope system in a GI endoscopy simulator. Aim-7: Validation of the system's oesophageal mucosal resurfacing performance in an in vivo porcine model, including tissue samples for histology examination at different time points.The action results are thought to mature the original design sufficiently for clinical trials and provide further steps for introducing the oesophageal mucosal resurfacing technique using non-thermal ablation into clinical routine.