Clinical trials: Nipple Sparing Mastectomy
Breast Cancer, Surgery--Complications
Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy
Nipple-sparing mastectomy (NSM) with immediate reconstruction is one of the standard of care surgical treatments of breast cancer (BC) and is used for risk reduction in patients with a high risk for BC.
- Conditions
- Breast Cancer, Surgery--Complications, Genetic Predisposition to Disease, Surgery
- Trial name
- RNSM (NCT04151368)
- Testing
- Robotic Nipple-Sparing Mastectomy (RNSM)
- Where
- Canada
- Volunteers
- 30 people
- Sponsor
- University Health Network, Toronto
Breast Cancer Female
Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy for Breast Cancer
This study will retrospectively collect and evaluate the surgical outcomes of robotic nipple sparing mastectomy (R-NSM) compared with endoscopic assisted NSM (E-NSM) or conventional NSM (C-NSM) in the management of breast cancer.
- Trial name
- RCENSM-R (NCT04049305)
- Testing
- Robotic assisted nipple sparing mastectomy (R-NSM), conventional nipple sparing mastectomy (C-NSM), Endoscopic assisted nipple sparing mastectomy (E-NSM)
- Where
- 13 sites in Italy, South Korea and 1 more
- Volunteers
- 900 people
- Sponsor
- Changhua Christian Hospital
Breast Cancer
Assessment of Nipple Sparing Mastectomy as a Treatment Option for Breast Cancer
Nipple-sparing mastectomy (NSM) with immediate breast reconstruction (IBR) is a form of mastectomy that achieves optimal disease control and facilitates reconstruction.
- Trial name
- NCT04640454
- Testing
- nipple sparing mastectomy
- Where
- Egypt
- Volunteers
- 35 people
- Sponsor
- Alexandria University
Skin Necrosis, Complication
Efficacy of Angiography With Indocyanine Green in the Identification of Complications After Breast Surgery
During the performance of oncoplastic surgery and skin-sparing or skin-nipple mastectomy there is a significant loss in the perfusion of the cutaneous envelope of the breast, which can produce areas of vascular suffering of the…
- Trial name
- NCT05910931
- Testing
- ICG angiography
- Where
- Spain
- Volunteers
- 221 people
- Sponsor
- University Hospital A Coruña
Breast Neoplasms, Germline BRCA1 Gene Mutation
Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
Robotic mastectomy and immediate reconstruction have been introduced in 2015. However, since robotic mastectomy is the latest surgical technique, there is a lack of studies prospectively comparing conventional mastectomy and…
- Conditions
- Breast Neoplasms, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Benign Breast Disease
- Trial name
- MARRES (NCT04585074)
- Testing
- Robotic or endoscopic nipple sparing mastectomy, Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)
- Where
- 18 sites in South Korea
- Volunteers
- 2,000 people
- Sponsor
- Severance Hospital
Breast Neoplasms
Impact of Robotic Versus Endoscopic Surgery on Nipple Nerve Function Following Nipple-Sparing Mastectomy for Breast Cancer
This is a multicenter, prospective, randomized parallel controlled two arm clinical trial, designed to systematically evaluate impact of robotic versus endoscopic surgery on breast nerve function in patients undergoing nipple…
- Trial name
- NCT07850154
- Testing
- Robotic-assisted nipple-sparing mastectomy, Endoscopic-assisted nipple-sparing mastectomy
- Where
- China
- Volunteers
- 374 people
- Sponsor
- Guangzhou Women and Children's Medical Center
Breast Cancer
Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction
This clinical trial aims to determine whether conventional surgery or endoscopic surgery results in better recovery of breast skin sensation in women with early-stage breast cancer undergoing nipple-sparing mastectomy with…
- Trial name
- NCT07372339
- Testing
- Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction, Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction
- Volunteers
- 170 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Breast Cancer, Mastectomy; Lymphedema
Same-Day Discharge After Nipple-sparing Mastectomy or Skin-sparing Mastectomy With Breast Reconstruction
This novel study will assess the feasibility and outcomes of same-day discharge following mastectomy with implant-based pre-pectoral reconstruction.
- Conditions
- Breast Cancer, Mastectomy; Lymphedema, Same Day Surgery, Nipple-sparing Mastectomy
- Trial name
- NCT04596683
- Testing
- Same-day NSM or SSM
- Where
- 3 sites in United States
- Volunteers
- 60 people
- Sponsor
- Georgetown University
Breast Reconstruction, Breast Cancer
Evaluation of Well Being and Patient Reported Outcomes After Robotic Single-port Nipple Sparing Mastectomy and Implant Reconstruction
This study is being carried out to better understand how different types of mastectomy surgeries affect women's recovery, satisfaction, and overall well-being after breast cancer surgery and reconstruction.
- Conditions
- Breast Reconstruction, Breast Cancer, Hereditary Breast/Ovarian Cancer (brca1, brca2), Robotic Surgery
- Trial name
- Reborn-i (NCT07236359)
- Testing
- Intervention, Standard open nipple sparing mastectomy with immediate implant-based reconstruction
- Volunteers
- 108 people
- Sponsor
- Beaumont Hospital
Breast Cancer, Ductal Carcinoma
Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction
The purpose of this research study is to see if a participant's nipple and areola can be safely preserved by adding radiation to these areas after a nipple-sparing mastectomy and immediate breast reconstruction.
- Trial name
- NCT01208974
- Testing
- Nipple-Sparing Mastectomy, Breast Reconstruction, Axillary Surgery
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- University of Miami
Postoperative Complications, Recurrence
Surgical and Oncologic Outcomes After Robotic Nipple Sparing Mastectomy and Immediate Reconstruction
Robotic mastectomy with immediate reconstruction was introduced by Toesca et al. in 2015. Since then, several studies have reported the safety and feasibility of robotic nipple-sparing mastectomy with immediate reconstruction.
- Conditions
- Postoperative Complications, Recurrence, Breast Neoplasms, Breast Cancer
- Trial name
- SORI (NCT04108117)
- Testing
- Robotic nipple sparing mastectomy
- Where
- South Korea
- Volunteers
- 659 people, healthy volunteers welcome
- Sponsor
- Severance Hospital
Breast Cancer
Nipple Delay Prior to Nipple Sparing Mastectomy: A Pilot RCT
The goal of nipple-sparing mastectomy (NSM) with immediate breast reconstruction is to reconstruct a breast mound with preservation a patient's natural skin envelope.
- Trial name
- NCT02526719
- Testing
- Nipple Delay surgery
- Sponsor
- University Health Network, Toronto
Breast Cancer
A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy
The goal of this study is to study nipple-areolar complex (NAC) sparing mastectomy as an alternative procedure to the standard skin-sparing mastectomy for women who have breast cancer or are at high-risk for developing breast…
- Trial name
- NCT00539227
- Testing
- NAC Sparing Mastectomy, Questionnaire
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer
Therapeutic Nipple Sparing Mastectomy.
This is a phase III, multicentric, single arm study with a sequential design using the exact conditional Poisson test. The primary objective of this prospective study is to evaluate whether selected breast carcinoma patients…
- Trial name
- MAPAM-01 (NCT02311959)
- Testing
- Nipple sparing mastectomy
- Where
- 33 sites in France
- Volunteers
- 450 people
- Sponsor
- Institut Claudius Regaud
Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer
Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer, High Risk Breast Carcinoma
- Trial name
- NCT06823414
- Testing
- Video assisted mastectomy
- Where
- Spain
- Volunteers
- 126 people
- Sponsor
- Alejandra García-Novoa
Breast Cancer, Reconstructive Breast Surgery
Using A Dissolved Oxygen Enriched Dressing in Nipple-sparing Mastectomy
This study will evaluate the effect of OxyGenesys Dissolved Oxygen Dressing in wound complication rates of the nipple areolar complex after a nipple sparing mastectomy.
- Trial name
- NSM (NCT01796977)
- Testing
- OxyGenesys Dissolved Oxygen Dressing, Standard Gauze Dressing
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Halyard Health
Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8
Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction
This phase II trial tests the willingness of patients undergoing nipple sparing mastectomy (NSM) to enroll in a randomized study of NSM with or without neurotization of the nipple areolar complex (NAC).
- Conditions
- Anatomic Stage 0 Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8
- Trial name
- NCT06153836
- Testing
- Neurotization Procedure, Questionnaire Administration, Subcutaneous Mastectomy
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Mayo Clinic
Breast Cancer, Nipple Sparing Mastectomy
Comparison of Nipple-areolar Complex Sensation According to Incision Types in Nipple-sparing Mastectomy
This study aims to assess nipple areolar complex sensation after nipple sparing mastectomy and compare the results according to different incisional approaches; specifically, inframammary fold (IMF) versus peri-areolar/radial.
- Trial name
- NCT05917834
- Testing
- Nipple sparing mastecomy with different incision placements
- Where
- South Korea
- Volunteers
- 105 people
- Sponsor
- Gangnam Severance Hospital