Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment
NCT ID: NCT05946759
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
54 participants
INTERVENTIONAL
2023-10-10
2024-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Prospective
50 prospective subjects
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.
Historical
40 historical subjects
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
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St. Vincenz Krankenhaus GmbH, Paderborn
UNKNOWN
SamanTree Medical SA
INDUSTRY
Responsible Party
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Principal Investigators
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Michael P Lux, Prof. Dr MBA
Role: PRINCIPAL_INVESTIGATOR
St. Vincenz Krankenhaus GmbH, Paderborn
Locations
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St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise
Paderborn, , Germany
Countries
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Other Identifiers
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SHIELD
Identifier Type: -
Identifier Source: org_study_id
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