Clinical trial · Interventional
Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction
NCT02673268CI-TRIAL-00029890MARCIunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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. The interest is to avoid scars on the breast. The scars are limited to the armpit and under the arm. The aim is also to study the rate of complications, cosmetic results and quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Da Vinci Robot Xi | Device | — | UNRESOLVED |
| Mastectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with breast cancer
- interventionNames
- Procedure: Mastectomy
- Device: Da Vinci Robot Xi
Primary outcomes (1)
- measure
- Rate of necrosis
- timeFrame
- Assessed up to 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDSarfati 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. PMID 29959612