Trials / Completed
CompletedNCT05946759
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment in a Single-centric PMPF Study (SHIELD)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 54 (actual)
- Sponsor
- SamanTree Medical SA · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Histolog Scanner | The PMPF study is collecting data that includes the use of the CE Mark IVD Histolog Scanner for the breast lumpectomy margin assessment. |
Timeline
- Start date
- 2023-10-10
- Primary completion
- 2024-03-12
- Completion
- 2024-03-12
- First posted
- 2023-07-14
- Last updated
- 2024-03-21
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT05946759. Inclusion in this directory is not an endorsement.