This is a minimal risk post-market registry study conducted at participating clinical institutions that are utilizing LumiSystem consistent with the U.S. Food and Drug Administration (FDA) approved indication for use to collect data on the use of LumiSystem in a real-world setting to support the evaluation of safety, effectiveness, clinical utility (including impact to healthcare utilization and surgical management), and product and quality improvements.
Participant must be consistent with FDA approved indication
Participant is enrolled in a clinical trial using an investigational product directing tissue removal during the lumpectomy procedure
This is a post-market registry study enrolling participants for whom LumiSystem was used during lumpectomy consistent with the FDA-approved indication for use
Cohort
Prospective
Not listed
Characterize removal of residual cancer in the lumpectomy bed of breast cancer patients.
Proportion of patients who have residual cancer found in at least one LumiSystem-guided shave among all patients.
Determine change in margin status after using LumiSystem
Proportion of patients with at least one positive margin on the index standard lumpectomy that were converted to final negative margins after usual care due to LumiSystem directed shaves among all patients and Proportion of patients with at least one positive margin on index standard lumpectomy that were converted to final negative margins after usual care due to LumiSystem directed shaves among patients with at least one positive margin on standard lumpectomy.
Determine impact to adjuvant radiotherapy treatment after using LumiSystem.
Proportion of patients whose adjuvant radiotherapy treatment provider reported a change in treatment recommendation or plan due to information received by use of LumiSystem.
Determine impact to surgical intervention after using LumiSystem
Assess clinical utility of LumiSystem use.
Compare LumiSystem performance against standard of care (SoC)
Proportion of LumiSystem-guided shaves that did not contain residual cancer taken after negative margins vs. proportion of standard of care (SoC) shaves that did not contain residual cancer taken after negative margins and proportion of LumiSystem-guided shaves taken after positive margins among positive margins vs. proportion of SoC shaves after positive margins among positive margins.
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This trial is not recruiting at the moment. You can still explore other options:
