Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-02-20 @ 8:27 PM
Study NCT ID:
NCT05946759
Status:
COMPLETED
Last Update Posted:
2024-03-21
First Post:
2023-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2023-06-27', 'studyFirstSubmitQcDate': '2023-07-06', 'lastUpdatePostDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reoperation Rate', 'timeFrame': '2-30 days post Breast Surgery', 'description': 'Differences in the rate of reoperation due to cancer positive margins'}], 'secondaryOutcomes': [{'measure': 'Margin status of intraoperative specimen vs. postoperative pathology assessment [Clinical Performance]', 'timeFrame': '0-30 days post Breast Surgery', 'description': 'To observe real life clinical performance of the HLS and accessories when used intraoperatively'}, {'measure': 'System Usability Scale (SUS) of the IVD device and accessories [Usability]', 'timeFrame': 'Only during the time of the breast surgery', 'description': 'To survey usability of the HLS and accessories when used intraoperatively'}, {'measure': 'Change in hospital cost with or without IVD device and accessories [Economic Impact]', 'timeFrame': '30 days post surgery date', 'description': 'To evaluate the economic impact for the hospital/payer of the reoperation rate'}, {'measure': 'Incidence of adverse device effects [Safety]', 'timeFrame': 'Only during the time of the breast surgery', 'description': 'Incidence of adverse device effects during surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reoperation Rate', 'Breast Conserving Surgery', 'Confocal laser scanning microscope', 'Confocal microscopy'], 'conditions': ['Breast Cancer - Ductal Carcinoma in Situ (DCIS)', 'Breast-Conserving Surgery']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult female Subject ≥18 years old.\n* Subject Scheduled for breast conserving surgery of invasive and/or in-situ ductal carcinoma.\n* Subject is able to read, understand and sign the informed consent.\n\nExclusion Criteria:\n\n* Subject previously treated for ipsilateral breast cancer and/or ductal carcinoma in situ surgery.\n* Subject with previous radiotherapy of the ipsilateral breast.\n* Subject with multicentric/multilateral breast cancer.\n* Subject with planned mastectomy, tumor-adapted breast reduction.\n* Subject with pre-surgical/ preoperative neo-adjuvant treatment.\n* Subject is pregnant/ lactating.\n* Participation in any other clinical study that would affect data acquisition.'}, 'identificationModule': {'nctId': 'NCT05946759', 'acronym': 'SHIELD', 'briefTitle': 'Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment', 'organization': {'class': 'INDUSTRY', 'fullName': 'SamanTree Medical SA'}, 'officialTitle': 'Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment in a Single-centric PMPF Study (SHIELD)', 'orgStudyIdInfo': {'id': 'SHIELD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Prospective', 'description': '50 prospective subjects', 'interventionNames': ['Device: Histolog Scanner']}, {'type': 'NO_INTERVENTION', 'label': 'Historical', 'description': '40 historical subjects'}], 'interventions': [{'name': 'Histolog Scanner', 'type': 'DEVICE', 'description': 'The PMPF study is collecting data that includes the use of the CE Mark IVD Histolog Scanner for the breast lumpectomy margin assessment.', 'armGroupLabels': ['Prospective']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paderborn', 'country': 'Germany', 'facility': 'St. Vincenz-Krankenhaus GmbH, Frauenklinik St. Louise', 'geoPoint': {'lat': 51.71905, 'lon': 8.75439}}], 'overallOfficials': [{'name': 'Michael P Lux, Prof. Dr MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Vincenz Krankenhaus GmbH, Paderborn'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SamanTree Medical SA', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'St. Vincenz Krankenhaus GmbH, Paderborn', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}