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Clinical Trials in the USA / NCT07616856
Recruiting Observational

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

NCT07616856 · tracked via the Priya Life Science USA tracker
Sponsor
Lumicell, Inc
Phase
Observational
Started
2026-09-30
Last updated
2026-10-22

Condition(s) studied

Breast Cancer

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Characterize removal of residual cancer in the lumpectomy bed of breast cancer patients. — Approximately 7 days
    Proportion of patients who have residual cancer found in at least one LumiSystem-guided shave among all patients.

Trial sites (2)

FacilityCityRegionStatus
University of South Alabama Health Mobile Alabama Recruiting
Stanford University Palo Alto California Recruiting

More Lumicell, Inc. trials in the USA

Post-market Safety Study of LUMISIGHT Recruiting
Feasibility of the LUM Imaging System for Detection of Gastrointestinal Cancers Recruiting

Other trials for the same condition

Sample Collection for Ongoing Research and Product Evaluation Study Recruiting
A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01) Active, not recruiting
Trastuzumab Deruxtecan (T-DXd) Alone or in Sequence With THP, Versus Standard Treatment (ddAC-THP), in HER2-positive Early Breast Cancer Active, not recruiting
A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy Recruiting
Basket Study of Entrectinib (RXDX-101) for the Treatment of Patients With Solid Tumors Harboring NTRK 1/2/3 (Trk A/B/C), ROS1, or ALK Gene Rearrangements (Fusions) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07616856 on ClinicalTrials.gov ↗ ← All trials in the USA