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| Name | Class |
|---|---|
| St. Vincenz Krankenhaus GmbH, Paderborn | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective | Active Comparator | 50 prospective subjects |
|
| Historical | No Intervention | 40 historical subjects |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Histolog Scanner | Device | The PMPF study is collecting data that includes the use of the CE Mark IVD Histolog Scanner for the breast lumpectomy margin assessment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Reoperation Rate | Differences in the rate of reoperation due to cancer positive margins | 2-30 days post Breast Surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Margin status of intraoperative specimen vs. postoperative pathology assessment [Clinical Performance] | To observe real life clinical performance of the HLS and accessories when used intraoperatively | 0-30 days post Breast Surgery |
| System Usability Scale (SUS) of the IVD device and accessories [Usability] |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Lux, Prof. Dr MBA | St. Vincenz Krankenhaus GmbH, Paderborn | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise | Paderborn | Germany |
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To survey usability of the HLS and accessories when used intraoperatively |
| Only during the time of the breast surgery |
| Change in hospital cost with or without IVD device and accessories [Economic Impact] | To evaluate the economic impact for the hospital/payer of the reoperation rate | 30 days post surgery date |
| Incidence of adverse device effects [Safety] | Incidence of adverse device effects during surgery | Only during the time of the breast surgery |