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.