Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast-Conserving Surgery
Conditions
Keywords
Reoperation Rate, Breast Conserving Surgery, Confocal laser scanning microscope, Confocal microscopy
Brief summary
This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.
Interventions
DEVICEHistolog Scanner
The PMPF study is collecting data that includes the use of the CE Mark IVD Histolog Scanner for the breast lumpectomy margin assessment.
Sponsors
St. Vincenz Krankenhaus GmbH, Paderborn
SamanTree Medical SA
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult female Subject ≥18 years old. * Subject Scheduled for breast conserving surgery of invasive and/or in-situ ductal carcinoma. * Subject is able to read, understand and sign the informed consent.
Exclusion criteria
* Subject previously treated for ipsilateral breast cancer and/or ductal carcinoma in situ surgery. * Subject with previous radiotherapy of the ipsilateral breast. * Subject with multicentric/multilateral breast cancer. * Subject with planned mastectomy, tumor-adapted breast reduction. * Subject with pre-surgical/ preoperative neo-adjuvant treatment. * Subject is pregnant/ lactating. * Participation in any other clinical study that would affect data acquisition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reoperation Rate | 2-30 days post Breast Surgery | Differences in the rate of reoperation due to cancer positive margins |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in hospital cost with or without IVD device and accessories [Economic Impact] | 30 days post surgery date | To evaluate the economic impact for the hospital/payer of the reoperation rate |
| Incidence of adverse device effects [Safety] | Only during the time of the breast surgery | Incidence of adverse device effects during surgery |
| System Usability Scale (SUS) of the IVD device and accessories [Usability] | Only during the time of the breast surgery | To survey usability of the HLS and accessories when used intraoperatively |
| Margin status of intraoperative specimen vs. postoperative pathology assessment [Clinical Performance] | 0-30 days post Breast Surgery | To observe real life clinical performance of the HLS and accessories when used intraoperatively |
Countries
Germany
Outcome results
None listed