Placebo control study

This design gives the clearest view of a device's specific effect, especially for endpoints that patients report themselves, such as pain. It depends on keeping the blinding, so subjects cannot tell sham from active treatment.

A comparative investigation in which the results of the use of a particular investigational device are compared with those from an ineffective device used under similar conditions.

FDA guidance: Design Considerations for Pivotal Clinical Investigations for Medical Devices (November 2013), Section 11, Glossary