The purpose of this study is to evaluate the performance of the SAVI SCOUT® Surgical
Guidance System (SAVI SCOUT). The SAVI SCOUT is a medical device, used to provide
real-time guidance during localized excisional biopsy or lumpectomy procedures, by
helping the surgeon locate and remove the desired tissue (i.e., the lesion and
surrounding normal tissue). The SAVI SCOUT has been 510K cleared.
The SAVI SCOUT is intended to assist surgeons in the location and retrieval of a
non-palpable abnormality as localized by radiographic or ultrasound methods. In this
study, the ability of the SAVI SCOUT to guide surgeons to find a lesion will be evaluated
instead of the standard technique of wire localization.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02370082.
Using radiography or ultrasound guidance, the SAVI SCOUT reflector will be placed
percutaneously up to 7 days prior to the scheduled excisional procedure. During surgical
excision, the SAVI SCOUT system will be used to locate the reflector, which will be
removed along with the surrounding breast tissue.
Final data analysis will be completed within 1 month after the last patient is treated.
Final assessment of the surgical results will be completed by the surgeon during a
routine follow-up visit within 1 month following the surgical excision or lumpectomy
procedure.
Main Objective: to show that the SAVI SCOUT technique can be used to safely and
effectively locate a non-palpable breast lesion during a localized excisional biopsy or
lumpectomy procedure.
Up to 10 sites and 150 patients will be enrolled.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationCianna Medical, Inc.
