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Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment (SHIELD)

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ClinicalTrials.gov Identifier: NCT05946759
Recruitment Status : Completed
First Posted : July 14, 2023
Last Update Posted : March 21, 2024
Sponsor:
Collaborator:
St. Vincenz Krankenhaus GmbH, Paderborn
Information provided by (Responsible Party):
SamanTree Medical SA

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer - Ductal Carcinoma in Situ (DCIS) Breast-Conserving Surgery Device: Histolog Scanner Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment in a Single-centric PMPF Study (SHIELD)
Actual Study Start Date : October 10, 2023
Actual Primary Completion Date : March 12, 2024
Actual Study Completion Date : March 12, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Prospective
50 prospective subjects
 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.
No Intervention: Historical
40 historical subjects


Outcome Measures
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Primary Outcome Measures :
  1. Reoperation Rate [ Time Frame: 2-30 days post Breast Surgery ]
    Differences in the rate of reoperation due to cancer positive margins


Secondary Outcome Measures :
  1. Margin status of intraoperative specimen vs. postoperative pathology assessment [Clinical Performance] [ Time Frame: 0-30 days post Breast Surgery ]
    To observe real life clinical performance of the HLS and accessories when used intraoperatively

  2. System Usability Scale (SUS) of the IVD device and accessories [Usability] [ Time Frame: Only during the time of the breast surgery ]
    To survey usability of the HLS and accessories when used intraoperatively

  3. Change in hospital cost with or without IVD device and accessories [Economic Impact] [ Time Frame: 30 days post surgery date ]
    To evaluate the economic impact for the hospital/payer of the reoperation rate

  4. Incidence of adverse device effects [Safety] [ Time Frame: Only during the time of the breast surgery ]
    Incidence of adverse device effects during surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05946759


Locations
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Germany
St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise
Paderborn, Germany
Sponsors and Collaborators
SamanTree Medical SA
St. Vincenz Krankenhaus GmbH, Paderborn
Investigators
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Principal Investigator: Michael P Lux, Prof. Dr MBA St. Vincenz Krankenhaus GmbH, Paderborn
More Information
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Responsible Party: SamanTree Medical SA
ClinicalTrials.gov Identifier: NCT05946759    
Other Study ID Numbers: SHIELD
First Posted: July 14, 2023    Key Record Dates
Last Update Posted: March 21, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by SamanTree Medical SA:
Reoperation Rate
Breast Conserving Surgery
Confocal laser scanning microscope
Confocal microscopy
Additional relevant MeSH terms:
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Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ