RADIOSO MILAN I (RADar Reflector localisatiOn-SCOUT for carcinOma Mammae, the MILAN IEO Experience I)
European Institute of Oncology
300 participants
Feb 1, 2023
OBSERVATIONAL
Conditions
Summary
This is a monocentric prospective observational study for patients with clinical undetectable breast lesions and indications to breast conserving surgery for histological characterization. The SCOUT® Radar occult breast lesion Localization (SRL) consists of an implantable reflector, a detector handpiece and a console and it uses non-radioactive micro-impulses to guide surgical excision in real time. The study describes the experience with 300 patients at the European Institute of Oncology. The primary endpoints of the study are the rates of successful positioning, localization and recovery of the reflector SRL.
Eligibility
Inclusion Criteria6
- Diagnosis of nonpalpable breast or lymph nodes
- Patients referred to IEO for breast surgery
- Patients between 18 and 90 years old
- Female patients
- Conservative surgery
- Patients willing and able to follow the study procedures and available for follow-up over the entire duration of the study
Exclusion Criteria2
- Patients known or suspected to be allergic to materials similar to those in the SAVI SCOUT components (nickel)
- Any condition that may expose the individual to a higher risk or preclude the study from achieving full compliance or completion.
Interventions
The SCOUT® Radar occult breast lesion Localization (SRL) uses non-radioactive micro-impulses to guide surgical excision in real time.
Locations(1)
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NCT05963464