Interpretation
The clinical research team were able to propose evidence-based modifications to the device design and provide clarity on recommendations for clinical parameters for use. The objective of confirming a finalised IFU was not met. For some operative steps a consensus was easily acquired as to the recommended course of action. However for others more data and experience are required. Case studies provided a comprehensive, contextualised data to support rapid evaluation which significantly contributed to the understanding the Odon Device in clinical practice.
Two further Odon Device feasibility studies, which are currently recruiting in the UK and France, aim to address the unanswered aspects of optimal device use, specifically the technique.