Exploratory Study Comparing ClearSight System 2D Map to Post Surgery Histopathological Analysis in Lumpectomy

This study is a multicenter, non-randomized, cross-sectional comparative exploratory study
comparing the ClearSight System 2D map results to post surgery histopathological analysis of
excised mass in lumpectomy surgery. The Efficacy Objective is to assess the ability of the
ClearSight™ System to detect malignant tissue less than or equal to 1 mm of margins of
excised breast specimen in breast conserving surgery using histopathological assessment as
reference. The Safety Objective is that all adverse events, serious adverse events (SAE)
will be reported according to local regulations. The actual reporting is discussed in
section 0. No device-related adverse events are expected. For more information please refer
to the Investigator Brochure.

Inclusion Criteria:

1. Women histologically diagnosed with carcinoma of the breast, scheduled for primary
lumpectomy (partial mastectomy) procedure.

2. Age ≥18.

3. Signed ICF

Exclusion Criteria:

1. Prior surgical procedure in the same breast within 12 months prior to the surgery
date.

2. Recurrent breast cancer surgery.

3. Neoadjuvant chemotherapy.

4. Previous radiation therapy to the operated breast.

5. Pregnant / breast feeding.

6. Participating in any other study that might affect results.