ClearEdge Device for Breast Cancer Surgery
Trial Summary
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, if you are currently receiving chemotherapy, you cannot participate in this trial.
What data supports the effectiveness of the ClearEdge Device treatment for breast cancer surgery?
The ClearEdge Device is designed to help surgeons check if all cancerous tissue has been removed during breast cancer surgery, which is important to prevent cancer from coming back. Similar devices, like MarginProbe, have been shown to reduce the need for additional surgeries by helping ensure all cancerous tissue is removed in the first operation.12345
How does the ClearEdge Device treatment differ from other breast cancer surgery treatments?
What is the purpose of this trial?
This trial is testing whether using the ClearEdge imaging device during breast cancer surgery can help doctors remove all cancerous tissue in one go, reducing the need for repeat surgeries. The device helps surgeons see if the edges of the removed tissue still have cancer cells.
Research Team
Jasmine Wong, MD
Principal Investigator
University of California, San Francisco Medical Center
Eligibility Criteria
This trial is for women over 18 with breast DCIS or invasive cancer who are recommended for a lumpectomy. It's not open to those who've had previous surgery or radiation on the same breast, are pregnant or breastfeeding, currently on chemotherapy, have implants, or were in another surgical breast cancer study recently.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Treatment
Participants undergo breast conserving surgery with or without the ClearEdge device for margin assessment
Follow-up
Participants are monitored for safety and effectiveness after surgery
Treatment Details
Interventions
- ClearEdge Device
Find a Clinic Near You
Who Is Running the Clinical Trial?
LS BioPath
Lead Sponsor