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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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study collects data on LumiSystem during regular medical care to learn how safe it is, how well it works, and how it affects surgery and health care use. It is for people whose use of LumiSystem fits the use approved by the U.S. Food and Drug Administration (FDA).

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Your use of LumiSystem must fit the use approved by the FDA.

Who can't join

  • You are in another clinical trial using an experimental product to guide tissue removal during a lumpectomy (surgery to remove a lump from the breast).

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

CA