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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

220 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-31

Study Completion Date

2018-11-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ClearSight™ System

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.

ClearSight™ System

Intervention Type DEVICE

comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.

Interventions

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ClearSight™ System

comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No