Introduction

Regulatory requirement for post-market surveillance of a device for multi-national company.

Aim

Review and revise clinical trial methodology.

Method

Experience in high quality studies and an evidence-based review of the most important and impactful outcome measures for specific use-case created a far tighter and efficient study.

Conclusion

Significant uptake/buy-in by stakeholder/trial-lead clinicians as widespread approval without revision by governing ethical committees. Trial continues to generate impactful data of use not only for governance and publication, but also in supporting procurement by end-prescribers due to demonstratable clinical and health economic outcome measures designed into the trial.