Confocal Histolog Scanner in Routine Breast-Conserving Surgery
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Switzerland
HFR
RECRUITING
Villars-sûr-glâne
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 100
Treatments
Experimental: Breast Cancer patient with Lumpectomy
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.
Related Therapeutic Areas
Sponsors
Leads: University of Fribourg