Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2026-02-17 @ 9:02 PM
Study NCT ID:
NCT02673268
Status:
UNKNOWN
Last Update Posted:
2017-10-12
First Post:
2016-02-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008408', 'term': 'Mastectomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2020-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-10-11', 'studyFirstSubmitDate': '2016-02-01', 'studyFirstSubmitQcDate': '2016-02-02', 'lastUpdatePostDateStruct': {'date': '2017-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of necrosis', 'timeFrame': 'Assessed up to 1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'referencesModule': {'references': [{'pmid': '29959612', 'type': 'DERIVED', 'citation': 'Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to demonstrate the feasibility of a mastectomy with conservation of the areola using axillary way only with the Da Vinci Robot Xi and immediate breast reconstruction using prosthesis.\n\nThe interest is to avoid scars on the breast. The scars are limited to the armpit and under the arm.\n\nThe aim is also to study the rate of complications, cosmetic results and quality of life.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1 .Patients with an indication of mastectomy with areola conservation 2. In case of carcinologic surgery:\n\n* Disease located more than 2cm of the areola on the clinical and paraclinical evaluation\n* Patients with indication of total mastectomy\n* Patients looking for immediate reconstruction 3. In case of prophylactic surgery\n* Patients wishing a prophylactic surgery because of highly risked mutation (BRCA1, BRCA2....) 4. Cup A, B or C maximum 5. Aged between 18 and 70 years old 6. OMS 0, 1 7. Signed informed consent 8. Patients affiliated to a social security system\n\nExclusion Criteria:\n\n1. Patients with a high risk of skin necrosis\n2. Planned post operative radiotherapy\n3. Patients with an historic of breast surgery on the side that needs to be operated\n4. Pregnant or breastfeeding women\n5. Persons deprived of liberty\n6. Persons not able to undergo medical follow up due to geographical, social or psychic reasons'}, 'identificationModule': {'nctId': 'NCT02673268', 'acronym': 'MARCI', 'briefTitle': 'Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Gustave Roussy, Cancer Campus, Grand Paris'}, 'officialTitle': 'Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction', 'orgStudyIdInfo': {'id': '2015-A00745-44'}, 'secondaryIdInfos': [{'id': '2015/2250', 'type': 'OTHER', 'domain': 'CSET number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with breast cancer', 'interventionNames': ['Procedure: Mastectomy', 'Device: Da Vinci Robot Xi']}], 'interventions': [{'name': 'Mastectomy', 'type': 'PROCEDURE', 'armGroupLabels': ['Patients with breast cancer']}, {'name': 'Da Vinci Robot Xi', 'type': 'DEVICE', 'armGroupLabels': ['Patients with breast cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94805', 'city': 'Villejuif', 'state': 'Val de Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Benjamin Sarfati, MD', 'role': 'CONTACT', 'email': 'Benjamin.sarfati@gustaveroussy.fr'}, {'name': 'Stefan Michiels, PhD', 'role': 'CONTACT', 'email': 'Stefan.michiels@gustaveroussy.fr'}], 'facility': 'Gustave Roussy Cancer Campus', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'centralContacts': [{'name': 'Benjamin Sarfati, MD', 'role': 'CONTACT', 'email': 'Benjamin.sarfati@gustaveroussy.fr', 'phone': '0142114384', 'phoneExt': '+33'}, {'name': 'Stefan Michels, PhD', 'role': 'CONTACT', 'email': 'Stefan.michiels@gustaveroussy.fr'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gustave Roussy, Cancer Campus, Grand Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}