RecruitingNot ApplicableNCT06958991

Confocal Histolog Scanner in Routine Breast-Conserving Surgery (CHiB)

Confocal Histolog Scanner in Routine Breast-Conserving Surgery


Sponsor

University of Fribourg

Enrollment

100 participants

Start Date

Jun 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of the CE mark product.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new scanner that uses reflected light (confocal microscopy) to examine the edges of tissue removed during breast-conserving surgery (a lumpectomy) in real time, while the patient is still in the operating room. The goal is to reduce the need for additional surgeries by more accurately checking whether the cancer was fully removed the first time. **You may be eligible if...** - You are a woman aged 18 or older - You are scheduled for breast-conserving surgery (lumpectomy) for invasive or in-situ (non-invasive) breast cancer - You are able to understand and sign the informed consent form **You may NOT be eligible if...** - You are planned to have a full mastectomy (complete breast removal) - You have a condition or circumstance that makes participation unsafe or impractical - You have had prior surgery on the same breast area being evaluated Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEHistolog Scanner

The clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of the CE mark product.


Locations(1)

HFR

Villars-sûr-glâne, Canton of Fribourg, Switzerland

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NCT06958991


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