NCT06958991Recruiting
Confocal Histolog Scanner in Routine Breast-Conserving Surgery (CHiB)
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.
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.
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- No phase (N/A)
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- University of Fribourg(Other)
- Protocol no.
- 2024-D0101
- Conditions
- Breast Cancer Invasive, Breast Cancer Surgery, Lumpectomy, Confocal Laser Endomicroscopy
- Interventions
- Device
Treatments studied
- Histolog Scanner
Locations · 1
- Villars-sûr-glâne, SwitzerlandHFRRecruiting at this site
In total, worldwide, the only site listed in the registry is recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: November 25, 2025).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
Other identifiers
- 20240829 · other grant
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.