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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07616856). StuddyBuddy aggregates publicly available trial information.