Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry
NCT07616856 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 1500
Last updated 2026-06-01
Summary
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.
Conditions
Sponsors & Collaborators
-
Lumicell, Inc.
lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-31
- Primary Completion
- 2030-12-31
- Completion
- 2030-12-31
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