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Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction (MARCI)

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ClinicalTrials.gov Identifier: NCT02673268
Recruitment Status : Unknown
Verified October 2017 by Gustave Roussy, Cancer Campus, Grand Paris.
Recruitment status was:  Recruiting
First Posted : February 3, 2016
Last Update Posted : October 12, 2017
Sponsor:
Information provided by (Responsible Party):
Gustave Roussy, Cancer Campus, Grand Paris

Study Description
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Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: Mastectomy Device: Da Vinci Robot Xi Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction
Actual Study Start Date : November 25, 2015
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with breast cancer Procedure: Mastectomy
Device: Da Vinci Robot Xi


Outcome Measures
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Primary Outcome Measures :
  1. Rate of necrosis [ Time Frame: Assessed up to 1 year ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02673268


Contacts
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Contact: Benjamin Sarfati, MD 0142114384 ext +33 Benjamin.sarfati@gustaveroussy.fr
Contact: Stefan Michels, PhD Stefan.michiels@gustaveroussy.fr

Locations
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France
Gustave Roussy Cancer Campus Recruiting
Villejuif, Val de Marne, France, 94805
Contact: Benjamin Sarfati, MD       Benjamin.sarfati@gustaveroussy.fr   
Contact: Stefan Michiels, PhD       Stefan.michiels@gustaveroussy.fr   
Sponsors and Collaborators
Gustave Roussy, Cancer Campus, Grand Paris
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier: NCT02673268    
Other Study ID Numbers: 2015-A00745-44
2015/2250 ( Other Identifier: CSET number )
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: October 12, 2017
Last Verified: October 2017