Home › Breast Cancer › NCT07616856
Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry
Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility
Who can join
Ages 18 and older · All sexes
Full 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
About the study
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.
Sponsor: Lumicell, Inc. · Participants: 1,500 · Started: Sep 30, 2026
Contact the study team
- VP, Clinical Affairs and Pharmacovigilance · Phone: 16174041033
Official record on ClinicalTrials.gov — NCT07616856
Locations in the U.S.
| Alabama | University of South Alabama Health, Mobile |
| California | Stanford University, Palo Alto |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.