Evaluation and Outcomes of SAVI Scout MD for Localized Breast Surgery
ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorH. Lee Moffitt Cancer Center and Research Institute
About this trial
The purpose of the study is to evaluate how precise the SAVI Scout MD is and how easy it is for surgeons to use during surgery. The SAVI Scout MD system uses tiny radar reflectors instead of wires, can be placed days or weeks before surgery, helps surgeons find the cancer more precisely and may lower the chance of needing a second surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult females who are 18 years of age or older at time of signing informed consent will be eligible.
Must have ability to comprehend and the willingness to sign written informed consent for study participation.
Patients must have at least one sonographically, mammographically, or MRI identifiable in-breast malignancy and consent to undergo a surgical resection requiring bracketed localization (more than one localizing marker) at Moffitt Cancer Center. Mammographically or sonographically visible biopsy clips may be used as a localizing target.
Disqualifiers
Patients undergoing mastectomy for resection of the targeted lesion.
Planned excision of multiple separate sites in the ipsilateral breast.
Inability to undergo surgery at Moffitt Cancer Center.
Trial design
Design model
Single group
Treatments tested in this trial
SAVI Scout MD system
DeviceImplantable radar reflector system allowing placement of multiple uniquely identifiable localizers for intraoperative tumor localization.
Treatment groups
37 Participants
are divided into 1 treatment groupGroup A: SAVI Scout MD LocalizationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Successful Operation Rate (SOR)
Proportion of patients achieving complete tumor resection with negative surgical margins ("no tumor on ink" or ≥2 mm for DCIS).
Time frame
Up to 6 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
H. Lee Moffitt Cancer Center and Research Institute
Lead sponsor
Merit Medical
Collaborator
Source ClinicalTrials.gov