Status:
RECRUITING
Confocal Histolog Scanner in Routine Breast-Conserving Surgery (CHiB)
Lead Sponsor:
University of Fribourg
Conditions:
Breast Cancer Invasive
Breast Cancer Surgery
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief 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 su...
Detailed Description
Breast cancer is the most common cancer in women. Moreover, numerous women have the diagnosis of a ductal carcinoma in situ (DCIS) each year, which can develop to invasive breast cancer without therap...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06958991
Start Date
June 1 2025
End Date
September 30 2026
Last Update
November 25 2025
Active Locations (1)
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1
HFR
Villars-sûr-glâne, Canton of Fribourg, Switzerland, 1752