The SAVI SCOUT Clinical Evaluation Study is currently enrolling and will accrue up to 150 patients. This trial is expected to be completed in the next few months. Since SCOUT is already FDA cleared, select geographic areas are targeted to receive the commercial product this summer. SCOUT will be available nationwide beginning Fall 2015.
In the clinical trial results, physicians are reporting SCOUT to be a very intuitive technology. Dr. Cox, Principal Investigator of the Clinical Evaluation Study and the completed Pilot Study, reported the following excerpt in Surgical Products (May 2015):
What kinds of training did the surgeons and radiologists receive before/while this study was conducted? Would this be the same for surgeons and radiologists not participating in the study?
“We’ve observed that clinicians are able to quickly learn how to use SAVI SCOUT and rapidly gain proficiency in breast tumor localization using the system. On average, it takes approximately two cases for most individuals to become comfortable and proficient with the procedure.
We would expect a similar learning curve for surgeons and radiologists not participating in the study. For surgeons, it’s a matter of mastering the deliberate movement of the handpiece and applying the correct amount of pressure. For radiologists, it’s simply adopting a slightly different technique when using the reflector delivery system.”
To accommodate the lead time necessary for evaluation and/or purchase approval of new technology, Cianna Medical is inviting interested sites to begin the process of setting up a 3 case evaluation. If interested please complete this short survey.