Focused Ultrasound Surgery Foundation

A clinical trial is an experiment using human subjects to test a theory about how a device will perform in people. 

• Some clinical trials, called feasibility or pilot studies, are very early in the development process and may carry more risk than other types of trials because less is known about how the device works in this indication. These trials are conducted in a small number of patients and the information learned here will aid in the development of a pivotal study design.
• Other clinical trials, called pivotal studies, are later in the development process and generally more is known about how the device will perform in people for this indication, but comparison against a known standard may be required in order for the device to be approved for commercial marketing. Sometimes the standard therapy is a ‘placebo’, ‘sham’, or ‘no therapy (using only best medical practice)’. Once these trials are completed, the device will be evaluated for safety and efficacy by a government agency for possible market approval. Sometimes the control group may be offered a cross-over option to the active treatment after a set length of follow-up time.
• Still other clinical trials, called post-market studies, are conducted after the device has been approved for commercial marketing, but additional information is needed: 
  • to determine long-term safety or as a condition of regulatory approval
  • for expanding the approval of the indication to other subpopulations
  • for evaluating improvements to the device
  • to collect more data regarding comparison to other standard treatments for payer determinations of coverage