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

Recruitingn/aAges 18 Years - anyAllLumicell, Inc.
NCT07616856 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Not listed
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Where

2 sites
University of South Alabama Health
Mobile, United States
Stanford University
Palo Alto, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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