Multi center, pivotal prospective, randomized clinical trial The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of DCIS or invasive cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.
Breast Cancer
Multi center, pivotal prospective, randomized clinical trial The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of DCIS or invasive cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.
Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
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UCSF Medical Center at Mission Bay, San Francisco, California, United States, 94158
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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18 Years to
FEMALE
No
LS BioPath,
Jasmine Wong, MD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco Medical Center
2024-12-31