Clinical trials: Mastectomy, Subcutaneous
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 Surgery
Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer
Patients with a germline pathogenic variant (GPV) in high-penetrance breast cancer susceptibility genes who are considering risk reducing mastectomy (RRM) often strongly desire to keep their nipple areola complex but inquire as…
- Trial name
- NSM (NCT06888388)
- Testing
- Nipple Sparing Mastectomy (NSM), Skin-Sparing Mastectomy (SSM), Total (Simple) Mastectomy
- Where
- 16 sites in United States, Australia and 6 more
- Volunteers
- 4,700 people
- Sponsor
- Sir Mortimer B. Davis - Jewish General Hospital
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
Breast Cancer Female
Robotic Versus Conventional or Endoscopic Nipple Sparing Mastectomy in the Management of Breast Cancer-Prospective Study
This study will prospectively evaluate the surgical outcomes of robotic nipple sparing mastectomy (NSM) compared with endoscopic assisted NSM or conventional NSM in the management of breast cancer.
- Trial name
- RCENSM-P (NCT04037852)
- Testing
- robotic assisted nipple sparing mastectomy, Endoscopic assisted nipple sparing mastectomy, Conventional nipple sparing mastectomy
- Where
- 11 sites in Taiwan
- Volunteers
- 180 people
- Sponsor
- Changhua Christian 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
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
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, BRCA 1 Gene Mutation
A Prospective CohorT Study of HandX - Assisted ENdoscopic MAstectomy: Feasibility and Safety (ATHENA I Study)
This study aims to learn whether a handheld robotic device, called the HandX, can help surgeons safely perform a minimally invasive nipple-sparing mastectomy.
- Conditions
- Breast Cancer, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation, Hereditary Breast Carcinoma
- Trial name
- ATHENA I (NCT07292246)
- Testing
- Endoscopic nipple sparing mastectomy, HandX endoscopic instrument
- Where
- Greece
- Volunteers
- 15 people
- Sponsor
- Vasileios Kalles
Breast Reconstruction, Implant-Based Breast Reconstruction (IBBR)
Pre- Versus Sub-pectoral Implant-based Breast Reconstruction After Skin-sparing Mastectomy or Nipple-sparing Mastectomy OPBC-02PREPEC
This trial is to investigate whether pre-pectoral Implant-Based Breast Reconstruction (IBBR) provides better Quality of Life (QoL) with respect to long-term (24 months) physical well-being (chest) compared to sub-pectoral IBBR…
- Trial name
- OPBC-02PREPEC (NCT04293146)
- Testing
- pre-pectoral IBBR, sub-pectoral IBBR
- Where
- 22 sites in United States, Austria and 5 more
- Volunteers
- 382 people
- Sponsor
- University Hospital, Basel, Switzerland
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, Breast Reconstruction
Endoscopic Nipple-Sparing Mastectomy (E-NSM) With Immediate Multistage Autologous Fat Grafting(IMAFG) for Total Breast Reconstruction Via the Axillary Incision
The goal of this clinical study is to evaluate the effectiveness and safety of a novel breast reconstruction technique combining endoscopic nipple-sparing mastectomy (E-NSM) with immediate multistage fat grafting (IMFG) in female…
- Trial name
- NCT07352137
- Testing
- endoscopic nipple-sparing mastectomy (E-NSM) with immediate implant-based reconstruction
- Where
- China
- Volunteers
- 20 people
- Sponsor
- Guangdong Provincial Hospital of Traditional Chinese Medicine
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
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
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
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 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
Nipple Areola Complex Conservation
96 patients were offered a nipple sparing mastectomy.
- Trial name
- NCT00641628
- Testing
- mastectomy
- Where
- Germany
- Sponsor
- Technical University of Munich
Sentinel Lymph Node Biopsy, Mastectomy, Subcutaneous
SLNB After Nipple Sparing Mastectomy
Sentinel Lymph Node Biopsy (SLNB) after nipple sparing mastectomy (NSM) is controversial. This study aims to investigate feasibility of SLNB with radioisotope method.
- Trial name
- NCT04140188
- Testing
- Senti-Scint (99mTc- pertechnetate combined with human albumin)
- Where
- Turkey (Türkiye)
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Acibadem University
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
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