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

Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Age Range:18 - 99
Start Date:October 2015
End Date:January 2017
Contact:Assaf Gur
Phone:: +972-8-6326004

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Clinical Study of the ClearSight™ System to Evaluate the Ability to Distinguish Malignant From Non-malignant Breast Tissue by Comparing MR Measurements of Freshly Excised Breast Tissue to Histopathology

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

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

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.
We found this trial at
529 West Markham Street
Little Rock, Arkansas 72205
(501) 686-7000
Phone: 501-686-6504
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
Little Rock, AR
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Phone: (972)89441693
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Washington, Washington 20037
Phone: 202-741-3270
Washington, WA
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