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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02673268 |
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Date of registration:
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01/02/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction
MARCI |
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Scientific title:
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Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction |
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Date of first enrolment:
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November 25, 2015 |
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Target sample size:
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80 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02673268 |
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Study type:
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Interventional |
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Study design:
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Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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France
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Contacts
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Name:
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Benjamin Sarfati, MD |
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Address:
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Telephone:
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0142114384 |
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Email:
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Benjamin.sarfati@gustaveroussy.fr |
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Affiliation:
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Name:
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Benjamin Sarfati, MD |
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Address:
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Telephone:
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Email:
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Benjamin.sarfati@gustaveroussy.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1 .Patients with an indication of mastectomy with areola conservation 2. In case of
carcinologic surgery:
- Disease located more than 2cm of the areola on the clinical and paraclinical
evaluation
- Patients with indication of total mastectomy
- Patients looking for immediate reconstruction 3. In case of prophylactic surgery
- 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
Exclusion Criteria:
1. Patients with a high risk of skin necrosis
2. Planned post operative radiotherapy
3. Patients with an historic of breast surgery on the side that needs to be operated
4. Pregnant or breastfeeding women
5. Persons deprived of liberty
6. Persons not able to undergo medical follow up due to geographical, social or psychic
reasons
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Procedure: Mastectomy
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Device: Da Vinci Robot Xi
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Primary Outcome(s)
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Rate of necrosis
[Time Frame: Assessed up to 1 year]
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Secondary ID(s)
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2015/2250
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2015-A00745-44
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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