Pilot Clinical Investigation: (i) Pilot clinical investigation is defined as those clinical investigations which are used to acquire specific essential information about a device before beginning the pivotal clinical investigation. Pilot clinical investigation is exploratory study which may be conducted in a few numbers of patients with the disease or condition being studied before moving to large population and scope that give insight into the performance and safety of a device but cannot provide definitive support for specific mechanistic or therapeutic claims. (ii) The objectives of a pilot clinical investigation typically include assessing feasibility (e.g. preliminary device performance), exploring eligibility criteria and their practical application for pivotal controlled investigation, ascertaining potential harm (preliminary safety evaluations), studying device mechanism, validating a method for determining an outcome measure, using a defined device mechanism to validate a surrogate outcome measure, and evaluating the logistics of pivotal investigation for performance.