An interventional study of Histolog Scanner in Breast Cancer - Ductal Carcinoma in Situ (DCIS) and Breast-Conserving Surgery, sponsored by SamanTree Medical SA. Completed at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by SamanTree Medical SA · Not applicable, Interventional, and Other
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.
363 studies on the registry are indexed under Carcinoma in Situ; 47 are open to participants now.
This study's enrollment of 54 is close to the median of 60 across 272 interventional studies indexed under Carcinoma in Situ.
Browse Carcinoma in Situ studies →SamanTree Medical SA is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
50 prospective subjects
Device: Histolog Scanner
40 historical subjects
The PMPF study is collecting data that includes the use of the CE Mark IVD Histolog Scanner for the breast lumpectomy margin assessment.
Reoperation Rate
Differences in the rate of reoperation due to cancer positive margins
Time frame: 2-30 days post Breast Surgery
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
Time frame: 0-30 days post Breast Surgery
System Usability Scale (SUS) of the IVD device and accessories [Usability]
To survey usability of the HLS and accessories when used intraoperatively
Time frame: 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
Time frame: 30 days post surgery date
Incidence of adverse device effects [Safety]
Incidence of adverse device effects during surgery
Time frame: Only during the time of the breast surgery
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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SamanTree Medical SA