Last updated on February 2018

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


Brief description of study

Prospective, single-arm, multicenter, open label, non-randomized exploratory clinical study comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.

Detailed Study Description

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.

Clinical Study Identifier: NCT02679378

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Kaplan Medical Center

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