Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry

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.

NCT Number	NCT07616856
Lead Sponsor	Lumicell, Inc.
Conditions	Breast Cancer
Enrollment	1,500 participants
Start Date	2026-07
Primary Completion	2030-12 (estimated)
Study Completion	2030-12 (estimated)
Updated on ClinicalTrials.gov	2026-06-01