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

Recruiting now · Not applicable

Conditions studied: Breast Cancer Invasive, Breast Cancer Surgery, Lumpectomy, Confocal Laser Endomicroscopy

In brief

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.

Key facts

Study ID

NCT06958991

Run by

University of Fribourg

People needed

100

Starts

2025-06-01

Expected to finish

2026-09-30

Last updated by the study team

2025-11-25

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Adult female Subject ≥18 years old.
• Subject scheduled for breast conserving surgery of invasive and/or in-situ ductal and lobular carcinoma.
• Subject is able to read, understand and sign the informed consent.

You may not qualify if…

• Subject with planned mastectomy
• Subject does not speak French- Subject with planned tumor-adapted breast reduction
• Subject is pregnant/ lactating. Subjects pregnant/lactating are excluded because such subjects are presenting additional risks during the surgery and they are also rare.
• Participation in any other clinical study that would affect data acquisition.

Where it is running

• HFR — Villars-sûr-glâne, Canton of Fribourg, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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