RecruitingNot Applicable

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

Switzerland100 participantsStarted 2025-06-01

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Reoperation Rate

Timeframe: From enrollment to the end of treatment (surgery) at 1 month

Trial details

NCT IDNCT06958991

SponsorUniversity of Fribourg

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-30

View on ClinicalTrials.gov More Breast Cancer Invasive trials