Confocal Histolog Scanner in Routine Breast-Conserving Surgery (CHiB)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Fribourg
About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Histolog Scanner
Treatment groups
100 Participants
are divided into 1 treatment groupLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
HFRRecruiting1752, Villars-sûr-glâne, Canton of Fribourg
Switzerland
SwitzerlandSponsors and collaborators
Source ClinicalTrials.gov