Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry
Recruiting
Observational Study
Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Observational
- Participants needed
- 1,500 (estimated)
- Sponsor
- Lumicell, Inc. · Industry
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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 s…
Trial Locations
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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
Contacts