Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment
SHIELD
1 other identifier
interventional
54
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2023
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 27, 2023
CompletedFirst Posted
Study publicly available on registry
July 14, 2023
CompletedStudy Start
First participant enrolled
October 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 12, 2024
CompletedMarch 21, 2024
March 1, 2024
5 months
June 27, 2023
March 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reoperation Rate
Differences in the rate of reoperation due to cancer positive margins
2-30 days post Breast Surgery
Secondary Outcomes (4)
Margin status of intraoperative specimen vs. postoperative pathology assessment [Clinical Performance]
0-30 days post Breast Surgery
System Usability Scale (SUS) of the IVD device and accessories [Usability]
Only during the time of the breast surgery
Change in hospital cost with or without IVD device and accessories [Economic Impact]
30 days post surgery date
Incidence of adverse device effects [Safety]
Only during the time of the breast surgery
Study Arms (2)
Prospective
ACTIVE COMPARATOR50 prospective subjects
Historical
NO INTERVENTION40 historical subjects
Interventions
The PMPF study is collecting data that includes the use of the CE Mark IVD Histolog Scanner for the breast lumpectomy margin assessment.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SamanTree Medical SAlead
- St. Vincenz Krankenhaus GmbH, Paderborncollaborator
Study Sites (1)
St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise
Paderborn, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Michael P Lux, Prof. Dr MBA
St. Vincenz Krankenhaus GmbH, Paderborn
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 27, 2023
First Posted
July 14, 2023
Study Start
October 10, 2023
Primary Completion
March 12, 2024
Study Completion
March 12, 2024
Last Updated
March 21, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share