A Prospective, Single Arm, Multi-site, Clinical Evaluation of a Nonradioactive Surgical Guidance Technology for the Location of Nonpalpable Breast Lesions during Excision
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Single-Port Robotic-assisted Transaxillary Breast-conserving Surgery: A Prospective, Single-arm, Non-randomized Phase IIa Clinical Trial
Published on: August 19, 2025
Charles E Cox1, Scott Russell1, Vanessa Prowler2
1USF Breast Health Program, University of South Florida, Tampa, FL, USA.
Objectives:
This study was a multicenter evaluation of the SAVI SCOUT(®) breast localization and surgical guidance system using micro-impulse radar technology for the removal of nonpalpable breast lesions. The study was designed to validate the results of a recent 50-patient pilot study in a larger multi-institution trial. The primary endpoints were the rates of successful reflector placement, localization, and removal.
Methods:
This multicenter, prospective trial enrolled patients scheduled to have excisional biopsy or breast-conserving surgery of a nonpalpable breast lesion. From March to November 2015, 154 patients were consented and evaluated by 20 radiologists and 16 surgeons at 11 participating centers. Patients had SCOUT(®) reflectors placed up to 7 days before surgery, and placement was confirmed by mammography or ultrasonography. Implanted reflectors were detected by the SCOUT(®) handpiece and console. Presence of the reflector in the excised surgical specimen was confirmed radiographically, and specimens were sent for routine pathology.
Results:
SCOUT(®) reflectors were successfully placed in 153 of 154 patients. In one case, the reflector was placed at a distance from the target that required a wire to be placed. All 154 lesions and reflectors were successfully removed during surgery. For 101 patients with a preoperative diagnosis of cancer, 86 (85.1 %) had clear margins, and 17 (16.8 %) patients required margin reexcision.
Conclusions:
SCOUT(®) provides a reliable and effective alternative method for the localization and surgical excision of nonpalpable breast lesions using no wires or radioactive materials, with excellent patient, radiologist, and surgeon acceptance.
Insights
The SAVI SCOUT system offers a wire-free, non-radioactive method for localizing nonpalpable breast lesions. This study confirms its high success rate in reflector placement and lesion removal, improving surgical outcomes.
Area of Science:
- Medical Devices
- Surgical Technology
- Oncology
Background:
- Nonpalpable breast lesions require accurate localization for effective surgical removal.
- Traditional localization methods often involve wires or radioactive seeds, which can cause patient discomfort and logistical challenges.
Purpose of the Study:
- To evaluate the SAVI SCOUT system, a micro-impulse radar technology, for breast lesion localization and surgical guidance.
- To validate the efficacy and reliability of the SCOUT system in a multicenter trial.
Main Methods:
- A prospective, multicenter trial involving 154 patients undergoing surgery for nonpalpable breast lesions.
- SAVI SCOUT reflectors were placed up to 7 days pre-surgery and confirmed radiographically.
- Surgical specimens were analyzed for reflector presence and margin status.
Main Results:
- Successful reflector placement in 153 of 154 patients (99.4%).
- All 154 lesions and reflectors were successfully removed during surgery.
- For patients with cancer (n=101), 85.1% achieved clear margins on initial excision.
Conclusions:
- The SAVI SCOUT system is a reliable and effective wire-free, non-radioactive alternative for localizing and excising nonpalpable breast lesions.
- The system demonstrated excellent acceptance among patients, radiologists, and surgeons.
