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

Completed

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT02679378

Run by

Clear Cut Medical Ltd.

People needed

220

Starts

2015-10-01

Expected to finish

2018-11-01

Last updated by the study team

2023-02-08

Who can join

Age: 18 and older, up to 99. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women histologically diagnosed with carcinoma of the breast, scheduled for primary lumpectomy (partial mastectomy) procedure.
• Age ≥18.
• Signed ICF

You may not qualify if…

• Prior surgical procedure in the same breast within 12 months prior to the surgery date.
• Recurrent breast cancer surgery.
• Neoadjuvant chemotherapy.
• Previous radiation therapy to the operated breast.
• Pregnant / breast feeding.
• Participating in any other study that might affect results.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• The George Washington University Hospital (GWU) — Washington D.C., District of Columbia, United States
• Kaplan Medical Center — Rehovot, Israel
• Assuta Medical Center — Tel Aviv, Israel
• Assaf Harofeh Medical Center — Ẕerifin, Israel

Full record on ClinicalTrials.gov

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