Robot Assisted Mastectomy Via Axillary Way With Areola Conservation and Immediate Reconstruction (MARCI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02673268|
Recruitment Status : Recruiting
First Posted : February 3, 2016
Last Update Posted : October 12, 2017
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Patients with breast cancer||
Device: Da Vinci Robot Xi
- Rate of necrosis [ Time Frame: Assessed up to 1 year ]
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
|Contact: Benjamin Sarfati, MD||0142114384 ext +33||Benjamin.firstname.lastname@example.org|
|Contact: Stefan Michels, PhD||Stefan.email@example.com|
|Gustave Roussy Cancer Campus||Recruiting|
|Villejuif, Val de Marne, France, 94805|
|Contact: Benjamin Sarfati, MD Benjamin.firstname.lastname@example.org|
|Contact: Stefan Michiels, PhD Stefan.email@example.com|