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

ConditionBreast Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLumicell, Inc.

About this trial

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

Qualifiers

Participant must be consistent with FDA approved indication

Disqualifiers

Participant is enrolled in a clinical trial using an investigational product directing tissue removal during the lumpectomy procedure

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

1,500 Participants
are grouped into 1 trial group

Locations

This trial has no locations

Sponsors and collaborators