Confocal Histolog Scanner for checking margins during lumpectomy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional clinical performance study uses a CE-marked Histolog® confocal laser scanning microscope to image excised breast tissue specimens intraoperatively and collect real‑world data on its use during breast‑conserving surgery. The device provides rapid, high‑resolution visualization of tissue microstructure to help surgeons identify positive margins and decide on immediate additional excision. Subjects are adult women undergoing lumpectomy for invasive cancer and/or DCIS and are managed according to routine surgical care with the scanner added into the intraoperative workflow. The primary focus is to observe reoperation rates when the Histolog Scanner is used for margin assessment in routine practice at the participating center.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Hfr
  Villars-sûr-glâne, Canton of Fribourg, Switzerland Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.