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

October 11, 2017 updated by: Gustave Roussy, Cancer Campus, Grand Paris

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with breast cancer
Procedure: Mastectomy
Device: Da Vinci Robot Xi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of necrosis
Time Frame: Assessed up to 1 year
Assessed up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 25, 2015

Primary Completion (Anticipated)

November 1, 2019

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

February 1, 2016

First Submitted That Met QC Criteria

February 2, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Actual)

October 12, 2017

Last Update Submitted That Met QC Criteria

October 11, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • 2015-A00745-44
  • 2015/2250 (Other Identifier: CSET number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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