Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures

Subjects randomized to this arm will undergo conventional open NSM procedures

Robotic-assisted Nipple sparing mastectomy procedures

Robotic NSM

open nipple-sparing mastectomy procedures

Open NSM

Kathryn Wine

Jennifer Tseng, MD

Stephanie Casal, MS, RN, CNS

Jamie Rand, MD

Mouchammed Agko, MD

Antoine Carre, MD

Katharine Schulz-Costello, DO

Farin Amersi, MD

Alice Chung, MD

Kjirsten Carlson, MD

Marissa Boyle, MD

Edward Ray, MD

Adna Makerevic

James Jakub, MD

Brian Rinker, MD

Sarah McLaughlin, MD

Olivia Ho, MD

Tammeza Gibson, PA

Cathy Graham, MD

Clara Farley, MD

Sarah Apatov, PA

Peter Thompson, MD

Duanny Alva

Anne Jankowski

Katherine Kopkash, MD

Nayana Dekhne, MD

Jesse Selber, MD

Mara Piltin, DO

Clinical Coordinator

Rebecca Aft, MD

Joani Christensen, MD

Sabah Iqbal

Alan Kadison, MD

Gary Deutsche, MD

Neil Tanna, MD

Armen Kasabian, MD

Kimberly Turnage, MSN

Adi Molvin

Akiko Chiba, MD

Shelley Hwang, MD

Laura Rosenberger, MD

Geoffrey Sisk, MD

Rebecca Knackstedt, MD

Maggie Dinome, MD

Juliana Ruiz

Ari Brooks, MD

Kathy Taylor

Kelly Hewitt, MD

John Tran

Rosa Hwang, MD

Solange Cox, MD

Renee Largo, MD

John Shuck, MD

Erin Fannon

Sara Javid, MD

Meghan Flanagan, MD

Suzanne Marie Inchauste, MD

Alysandra Lal, MD

John Yousif, MD

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM.

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Subjects undergo nipple-sparing mastectomy (NSM) procedures using the da Vinci SP Surgical System or open NSM

Robotic vs. Open NSM for Early Stage Breast Cancer

A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures

Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery

Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM

Incidence of positive surgical margins compared to open NSM

Intuitive Surgical

Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction

Open nipple-sparing mastectomy and immediate breast reconstruction with implant

Antonio Toesca, MD

This trial is designed to compare robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with conventional open technique. It is a prospective randomized trial evaluating patients satisfaction

High proportion of patients with newly diagnosed early-stage breast cancer in Europe and US undergo to mastectomy. The absolute numbers of mastectomy rates in US is still today around 38% and represent one of the most performed operation for cancer reasons. Despite the lack of a natural cavity needed for endoscopic viewing, applications of robotic surgery have recently emerged for superficial organs such as in the fields of thyroidectomy, oropharyngeal surgery, plastic and reconstructive surgery. However, it has never been applied in breast cancer except for a feasibility and safety study conducted at European Institute of Oncology.

The technique was firstly published by Toesca et al. considering the first 3 cases. The same research as continued on breast cancer evaluating feasibility, reproducibility and safety studying 26 consecutive procedures of robotic nipple sparing mastectomy and immediate robotic breast reconstruction (article under peer to peer review at European Journal of Surgical Oncology, EJSO). In these initial cases of robotic nipple sparing mastectomy and immediate breast reconstruction authors found two main advantages such as the robotic optical vision and the minimal invasiveness. The two main limitations noticed in this initial experience were the duration of operating time and the additional costs related to the operation. The limitations of the applicability of robotic surgery to the breast, such as operating time and costs, might be offset by the advantages they observed such as better vision and minimally invasive approach with an anatomically more respectful mastectomy.

This project is a superiority trial comparing robotic nipple sparing mastectomy and immediate breast robotic reconstruction with conventional open technique.

The primary end-point is to evaluate patient satisfaction. Second end-point is to compare post-operative outcome considering complications, post-operative pain, reduction of the average length of stay of patients, long term oncological outcome of the two different surgical techniques.

Patients will be randomized into two treatment arms:

A. Open nipple-sparing mastectomy and immediate breast reconstruction with implant (Open NSM) B. Robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with implant (Robotic NSM) Both arms will undergo to the same pre-surgical staging, intra-operative axillary surgical staging, post-operative multidisciplinary evaluation and adjuvant treatments according to international and internal protocols.

Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique

Robotic Nipple-Sparing Mastectomy And Immediate Robotic Breast Reconstruction Vs Conventional Open Technique: A Prospective Randomized Trial Evaluating Patients Satisfaction

The BREAST-Q survey is used to detect differences in patient satisfaction among the groups

Reduction of the average length of stay of patients of the two different surgical techniques.

Compare post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma)

Cumulative incidence of axillary recurrences

Cumulative incidence of distant recurrences

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Robotic vs. Open NSM for Early Stage Breast Cancer	NCT05720039	Breast Cancer F... Breast Cancer Breast Cancer, ... Breast Disease Breast	Robotic NSM Open NSM	21 Years -	Intuitive Surgical
Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique	NCT03440398	Breast Cancer	Robotic NSM Open NSM	18 Years -	European Institute of Oncology
Robotic vs. Open NSM for Early Stage Breast Cancer	NCT05720039	Breast Cancer F... Breast Cancer Breast Cancer, ... Breast Disease Breast	Robotic NSM Open NSM	21 Years -	Intuitive Surgical

Spots Global Cancer Trial Database for open nsm

Every month we try and update this database with for open nsm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for open nsm

Every month we try and update this database with for open nsm cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for open nsm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.