Lead Sponsor

Clear Cut Medical Ltd.

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

No

•1. Women histologically diagnosed with invasive and/or in situ carcinoma of the breast, undergoing primary lumpectomy (partial mastectomy) procedure
•2. Age ≥18
•3. Patient is willing and capable to provide written Informed Consent Form (ICF)

•4. Prior surgical procedure in the same breast within 12 months prior to the surgery date
•5. Recurrent breast cancer surgery
•6. Neoadjuvant chemotherapy and/or neoadjuvant hormone therapy
•7. Previous radiation therapy in the operated breast
•8. Pregnancy
•9. Lactation
•10. Patient has subglandular breast implants in the operated breast
•11. moribund patient and/or patient with comorbidities, per principal investigator discretion
•12. Participating in any other investigational study for either drug or device which might influence collection of valid data under this study.
•Intraoperative:
•13. Specimen undergoing pathological specimen assessment (e.g. by frozen section, imprint cytology or gross assessment by sectioning), resulting in deformation of specimen shape/tissue properties (e.g. Formalin conservation)
•14. Specimen dimension is larger than the Tissue container volume (200cc)
•15. Inability to define aspect color/orientation and/or margin border