LumiSystem in breast-conserving surgery: real-world use after market release

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry collects real-world data on the use of LumiSystem (LUMISIGHT pegulicianine and Lumicell DVS fluorescence imaging) during lumpectomy in adults with breast cancer. It aims to document safety, effectiveness, and clinical utility, including potential impacts on surgical decisions and healthcare utilization, under FDA-approved labeling. The study does not direct patient care but records information about procedures and outcomes when LumiSystem is used. Data are gathered from participating institutions under minimal risk and within routine clinical practice. The protocol emphasizes post-market surveillance and quality improvement for the device and imaging agent.

Why it matters

Who can join: the full rules

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

Where it's running

• University of South Alabama Health
  Mobile, Alabama, United States Recruiting
• Stanford University
  Palo Alto, California, United States Recruiting

Study contacts

• Study coordinator: VP, Clinical Affairs and Pharmacovigilance
• Email: kate@lumicell.com
• Phone: 16174041033

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.