Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:20 PM
Study NCT ID:
NCT01959867
Status:
WITHDRAWN
Last Update Posted:
2017-01-10
First Post:
2013-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-06', 'studyFirstSubmitDate': '2013-09-27', 'studyFirstSubmitQcDate': '2013-10-09', 'lastUpdatePostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Capsular Contracture Rate', 'timeFrame': '12 months Post-Exchange', 'description': 'Capsular Contracture Rate (Baker III/IV): Reduction from control through 12 months after expander-to-permanent implant exchange'}, {'measure': 'Breast Q', 'timeFrame': '12 months Post-Exchange', 'description': 'No decrease in overall patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, all questions a-p.\n\nIncrease in patient satisfaction from control as measured by the BREAST-Q Reconstruction Module Patient Satisfaction with Breasts survey, questions related to capsular contracture.'}], 'secondaryOutcomes': [{'measure': 'No. Capsule Procedures', 'timeFrame': '12 months Post-Exchange', 'description': 'Number of capsule procedures performed'}, {'measure': 'Cosmetic Assessment', 'timeFrame': '12 months Post-Exchange', 'description': 'Patient: (BREAST-Q Reconstruction Module) Surgeon: (panel review of standard photographs)'}, {'measure': 'Time to Completion', 'timeFrame': '12 months Post-Exchange', 'description': 'Time to Completion (expand-to-implant exchange)'}, {'measure': 'Total number of OR procedures', 'timeFrame': '12 month follow-up visit', 'description': 'Procedural Attributes: Total number of OR procedures'}, {'measure': 'Total number of visits', 'timeFrame': '12 month follow up visit', 'description': 'Procedural Attributes: Total number of ("in office" and OR procedures)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['mastectomy', 'breast reconstruction', 'bovine', 'ADM', 'breast cancer', 'breast implants', 'breast expanders', 'radiation therapy'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a prospective clinical study comparing two-stage breast reconstruction following mastectomy with and without the use of SurgiMend® PRS fetal bovine collagen matrix in patients with pre-mastectomy radiation therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient is at least 18 years of age\n* Patient is female\n* Patient is undergoing immediate, two-stage breast reconstruction following mastectomy with or without the use of SurgiMend® PRS\n* Patient has previously undergone pre-mastectomy XRT for breast cancer, with lumpectomy or partial mastectomy, with the previously irradiated breast now being reconstructed (with or without contralateral mastectomy \\& reconstruction)\n* Patient utilized a textured expander only\n* Patient utilized a smooth gel permanent implant only\n* Patient has agreed and is able to comply with the study follow-up requirements\n* Patient or guardian has provided consent for participation\n\nExclusion Criteria:\n\n* Patient is undergoing single-stage breast reconstruction\n* Patient is undergoing a delayed reconstruction\n* Patient is undergoing reconstruction using a smooth tissue expander, textured gel breast implant or any saline breast implant.\n* Patient is undergoing planned reconstruction using autologous tissue\n* Patient has a known hypersensitivity to collagen or bovine derived materials\n* Patient is currently pregnant, nursing, or planning a pregnancy during the course of the study\n* Patient who has had pre-mastectomy XRT bilaterally for breast cancer (either at the same time or separated in time)'}, 'identificationModule': {'nctId': 'NCT01959867', 'briefTitle': 'SurgiMend in Two-stage Implant-based Breast Reconstruction in Patients With Pre-Mastectomy Radiotherapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'Clinical Study Comparing Two-Stage Breast Reconstruction Following Mastectomy With and Without the Use of SurgiMend® PRS Fetal Bovine Collagen Matrix in Patients With Pre-Mastectomy Radiation Therapy', 'orgStudyIdInfo': {'id': 'TEI-BR-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SurgiMend® PRS (ADM)', 'description': 'Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).', 'interventionNames': ['Device: SurgiMend® PRS']}, {'type': 'OTHER', 'label': 'No Intervention', 'description': 'Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'SurgiMend® PRS', 'type': 'DEVICE', 'otherNames': ['ADM, acellular dermal matrix'], 'description': 'Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).', 'armGroupLabels': ['SurgiMend® PRS (ADM)']}, {'name': 'No Intervention', 'type': 'OTHER', 'description': 'Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).', 'armGroupLabels': ['No Intervention']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}