Clinical trials: Nipple Sparing Mastectomy
Breast Neoplasms
Intra-operative Radiotherapy For Breast Cancer Women After NSM
The role of NSM is still controversial, mainly because of concern about the oncologic safety of the nipple-areola complex (NAC).INTRABEAM (Carl Zeiss, Oberkochen, Germany) is the most widely used mobile intraoperative…
- Trial name
- NCT02389686
- Testing
- INTRABEAM (Carl Zeiss, Oberkochen, Germany)
- Where
- China
- Volunteers
- 110 people
- Sponsor
- Liao Ning
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
The Application of "HUAXI Hole 1" in Reverse-sequence Endoscopic Nipple-sparing Mastectomy With Direct-to-implant Breast Reconstruction
This study is a multicenter, open-label, randomized controlled trial. It will prospectively compare outcomes between patients undergoing reverse-sequence endoscopic NSM (R-E-NSM) with direct-to-implant breast reconstruction…
- Trial name
- HUAXI-h-01 (NCT06995118)
- Testing
- HUAXI hole 1
- Where
- 20 sites in China
- Volunteers
- 337 people
- Sponsor
- Du Zhenggui
Breast Cancer
Drain Removal on Postoperative Safety and Patient Satisfaction in R-E-NSM With Prepectoral DIBR
Breast cancer is a malignant tumor that seriously threatens the health of women, with an increasing incidence rate. The current main treatment methods include multidisciplinary diagnosis and treatment such as surgery…
- Trial name
- DRAIN (NCT07237828)
- Testing
- Drain Removal Timing After Endoscopic Breast Reconstruction Surgery
- Where
- China
- Volunteers
- 379 people
- Sponsor
- Du Zhenggui
Breast Neoplasms
The Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study
To balance the oncological safety and cosmetic outcome is the basic principle of modern breast surgery. To preserve the nipple-areolar complex shows attractive cosmetic advantage but concerns regarding local recurrence make the…
- Trial name
- NCT03105570
- Testing
- Areola Sparing Mastectomy
- Where
- China
- Volunteers
- 145 people
- Sponsor
- Peking University People's 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
Mastectomy, Breast Reconstruction
Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer
Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and when nerve sensation to the breast skin returns after mastectomy.
- Trial name
- NCT03135392
- Testing
- Breast Reconstruction with Artificial Implant, Autologous Breast Reconstruction, Neurotization
- Where
- United States
- Sponsor
- Case Comprehensive Cancer Center
Breast Cancer, Breast Reconstruction
Comparison of Safety and Patients-Reported Outcomes Between Single-Port Endoscopic and Conventional Nipple-Sparing Mastectomy With Immediate Implant Reconstruction
Why is this study being done? Breast cancer is very common among women. Today, patients not only seek effective treatment but also care about their quality of life after surgery, including how they feel and how satisfied they are…
- Trial name
- NCT07410728
- Where
- China
- Volunteers
- 471 people
- Sponsor
- Xijing Hospital
Surgery
SKINI - Radicality of Skin-Sparing and Nipple-Sparing Mastectomy
Prospective collection of health related personal data and biological material (tissue biopsy) in patients undergoing mastectomy.
- Trial name
- SKINI (NCT03470909)
- Testing
- Skin-Sparing Mastectomy (SSM), Nipple-Sparing Mastectomy (NSM)
- Where
- Switzerland
- Volunteers
- 160 people
- Sponsor
- Brust-Zentrum AG
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
Breast Cancer
Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique
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
- Trial name
- NCT03440398
- Testing
- Robotic NSM, Open NSM
- Where
- Italy
- Volunteers
- 82 people
- Sponsor
- European Institute of Oncology
Breast Carcinoma, Breast Reconstruction
Prepectoral and Subpectoral Implant-based Breast Reconstruction
Breast cancer is one of the main malignant tumors threatening women's lives. In recent years, the increasing demand for reconstruction of breast cancer patients in China has made the proportion of breast reconstruction increase…
- Trial name
- NCT04688697
- Testing
- prepectoral implant-based reconstruction, subpectoral implant-based reconstruction
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Fudan University
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
Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8
Prospective Registry Trial for Single Port Robot-assisted Nipple Sparing Mastectomy (SPrNSM)
This is a prospective registry trial to determine the outcomes of single port robot-assisted nipple sparing mastectomy (SPrNSM) utilitzing the SP da Vinci surgical system.
- Conditions
- Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- SPrNSM (NCT04866992)
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Stage II Breast Cancer, Stage I Breast Cancer
Comparison Between Prepectoral and Subpectoral Breast Reconstruction
There are controversies about breast implant-based reconstruction techniques. Our center pioneered single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) combined with stage I prosthesis reconstruction.
- Trial name
- RESPECT (NCT05833659)
- Testing
- The breast reconstruction method after single-port insufflation endoscopic nipple-sparing mastectomy
- Where
- China
- Volunteers
- 88 people
- Sponsor
- Beijing Friendship Hospital
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 Cancer
NAC Sparing Mastectomy After Neo-adjuvant Chemotherapy
Nipple areolar-complex (NAC) sparing mastectomy, extending the concept of skin-sparing mastectomy, allows to leave the nipple-areola complex intact and to provide a better cosmetic result.
- Trial name
- NCT02471742
- Testing
- NAC-sparing mastectomy, conventional mastectomy
- Where
- Italy
- Volunteers
- 573 people
- Sponsor
- Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Nipple-sparing Mastectomy, Prophylactic Mastectomy
Pilot Study of Single-port Robot-assisted Nipple-sparing Mastectomy
Nipple-sparing mastectomy (NSM) is indicated for breast cancer requiring total mastectomy and without nipple involvement by cancer.
- Conditions
- Nipple-sparing Mastectomy, Prophylactic Mastectomy, Breast Cancer, BRCA1 Mutation
- Trial name
- NCT05448963
- Testing
- da Vinci SPⓇ Single-port System
- Where
- Taiwan
- Volunteers
- 30 people
- Sponsor
- Chang Gung Memorial Hospital
Sensation Disorder
A Comparative Study of Nipple Sensation Preservation After Nipple-Sparing Mastectomy With Conventional, Endoscopic, Robotic Techniques
The goal of this comparative study is to learn how different surgical methods affect nipple and skin sensation after nipple-sparing mastectomy (NSM).
- Trial name
- NIPSENSE (NCT07062458)
- Testing
- Nipple Sensation Assessment
- Where
- Italy
- Volunteers
- 90 people
- Sponsor
- Candiolo Cancer Institute - IRCCS
Breast Cancer, High Risk of Breast Cancer
Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy
This is a single arm, single-center, prospective clinical trial designed to track the peri, post-operative and oncologic outcomes when utilizing the da-Vinci single port (SP) robotic platform to perform robotic nipple sparing…
- Trial name
- NCT05245812
- Testing
- da Vinci SP Surgical System
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Deborah Farr, MD
Breast Cancer
Feasibility and Acceptability of Endoscopic Mastectomy in Patients With Breast Cancer
Nipple -Sparing Mastectomy (NSM), with immediate breast reconstruction (IBR) can be offered to patients requiring mastectomy when the lesion is more than 2cm from the nipple.
- Trial name
- NEOMAMENDO (NCT06569706)
- Testing
- Nipple-Sparing Mastectomy, with immediate breast reconstruction
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Montpellier