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

Clear Cut Medical

Status: Completed

Conditions: Breast Cancer

Treatments: Device: ClearSight™ System

Study type: Observational

Funder types: Industry

Identifiers

NCT02679378

710CLD Rev. 02

Details and patient eligibility

About

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

Full 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.

Enrollment: 220 patients

Sex: Female

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

220 participants in 1 patient group

ClearSight™ System

Description:

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 when compared to histopathological assessment.

Treatment:

Device: ClearSight™ System