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Recruiting
NCT07616856
Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry
Conditions: Breast Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 1500
Sponsor: Lumicell, Inc.
Location: University of South Alabama Health Mobile Alabama
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Participant must be consistent with FDA approved indication
Exclusion Criteria:
* Participant is enrolled in a clinical trial using an investigational product directing tissue removal during the lumpectomy procedure
Source: ClinicalTrials.gov (NCT07616856). StuddyBuddy aggregates publicly available trial information.