Clinical trials: Mastectomy, Subcutaneous
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
Breast Cancer Classified as TNM Stage 0-IIIa
Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction
Research Purpose The present study is designed to generate the strongest evidence available on the role of robotic surgical systems in breast cancer surgery and to elucidate the clinical value of immediate breast reconstruction…
- Trial name
- ROM (NCT05490433)
- Testing
- Robot-assisted Nipple-Sparing Mastectomy (RNSM), Conventional nipple sparing mastectomy(CNSM)
- Where
- 17 sites in South Korea
- Volunteers
- 790 people
- Sponsor
- Yonsei University
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
Nipple-sparing Mastectomy, Immediate Prosthesis Reconstruction
Endoscopic and Robotic NSM with Immediate Prosthesis Breast Reconstruction
Breast cancer is the most common malignant tumor in women. Surgical treatment is the most important treatment for early breast cancer. Breast cancer resection is considered to be a destructive operation.
- Conditions
- Nipple-sparing Mastectomy, Immediate Prosthesis Reconstruction, Endoscopic Surgery, Robotic Surgery
- Trial name
- EnRoNSM (NCT06748677)
- Where
- China
- Volunteers
- 484 people
- Sponsor
- Peking University People's Hospital
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, 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
Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8
Prospective Pilot Study of Robot-assisted Nipple Sparing Mastectomy (RNSM)
This is a pilot study to determine safety, efficacy, and potential risks of robot assisted nipple sparing mastectomy (RNSM), by utilizing the daVinci surgical system.
- Conditions
- Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8
- Trial name
- NCT04537312
- Testing
- Robot-assisted Nipple Sparing Mastectomy, Survey Administration, RNSM
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Ohio State University Comprehensive Cancer Center
Surgical Managment of Gynecomastia
Evaluation of Feasibility and Aesthetic Outcomes of Benelli Technique for Nipple Sparing Mastectomy in Surgical Treatment of Grade 3 and 4 Gynecomastia
Gynecomastia is the benign proliferation of male breast tissue caused by an increase in the estrogen/androgen activity ratio. It manifests itself physiologically (adolescence, puberty, and old age) as well as pathologically…
- Trial name
- NCT06473064
- Testing
- Benelli technique for nipple sparing mastectomy in surgical treatment of grade 3 and 4 gynecomastia
- Where
- Egypt
- Volunteers
- 30 people
- Sponsor
- Assiut University
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 Reconstruction Following Mastectomy
Prospective Trial of Subcutaneous Versus Subpectoral 2-Staged Implant-Based Breast Reconstruction
This study is for women scheduled to have immediate breast reconstruction following mastectomy using a tissue expander. The primary purpose of this study is to learn whether there are differences in the outcome between placing…
- Trial name
- NCT02775409
- Testing
- Subcutaneous placement, Submuscular placement
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Mayo Clinic
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
Endoscopic Subcutaneous Mastectomy
ESM Versus OM ：A Randomized Controlled Trial
The consideration of quality of life issues has led to the development of alternative surgeries for breast cancer patients, particularly in the case of localized disease.
- Trial name
- NCT04461847
- Testing
- subcutaneous mastectomy, endoscopic subcutaneous mastectomy
- Where
- China
- Volunteers
- 287 people, healthy volunteers welcome
- Sponsor
- Beijing Friendship Hospital
Nipple Sparing Mastectomy
Open Nipple Sparing Mastectomy (NSM)
This is retrospective, multicenter chart review is to evaluate the complication rates of prophylactic open NSM procedures through 42 days postoperatively
- Trial name
- NSM Open (NCT04447339)
- Testing
- Nipple Sparing Mastectomy
- Where
- 5 sites in United States
- Volunteers
- 75 people
- Sponsor
- Intuitive Surgical
Breast Cancer
Local and Regional Radiotherapy for Nipple Sparing Mastectomy With Implant
The prospective observational study of radiation therapy is conducted on the nipple-areola complex(close resection margin at primary tumor site) or regional lymph nodes(including axilla and supraclavicular lymph node) with a high…
- Trial name
- NCT05213962
- Where
- South Korea
- Volunteers
- 128 people
- Sponsor
- National Cancer Center, Korea
Mastectomy; Lymphedema, Breast Cancer
Examining and Comparing the Temporal Changes and Results of Cosmetic, Quality of Life and Patient Satisfaction Achieved With Immediate and Delayed-immediate Implant-based Breast Reconstruction Procedures and Contralateral Symmetrization Techniques
This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of…
- Conditions
- Mastectomy; Lymphedema, Breast Cancer, Quality of Life
- Trial name
- NCT04356235
- Testing
- A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction, B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling, C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation
- Where
- Hungary
- Volunteers
- 528 people, healthy volunteers welcome
- Sponsor
- National Institute of Oncology, Hungary
Breast/Surgery
Nipple-sparing Mastectomy in Combined With Buried Flap Monitoring
1. Learning curve of ms-Tram and DIEP breast reconstructions surgery are important to guide the training of new surgeon. 2. Buried flap post operative monitoring without implantable doppler was seldom studied, a validated…
- Trial name
- NCT05560633
- Testing
- No intervention
- Volunteers
- 147 people, healthy volunteers welcome
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Breast Cancer
Localization of Intercostal Perforating Vessels Reduces Wound Complications From Nipple Sparing Mastectomy
Approximately 100 women scheduled for NSM will be consented pre-operatively to participate in the study. US will be performed after induction of general anesthesia, prior to surgery using Sonosite™ portable US, 5-12mHz transducer…
- Trial name
- NCT02938390
- Testing
- Ultrasound for localizing intercostal perforating vessels
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Amita Health
Breast Cancer, Mastectomy; Lymphedema
Examining the Cosmetic Results, Quality of Life and Patient Satisfaction Achieved With Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction, and Comparing it to Classic Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgeries
This is a response-adaptive (RAR) prospective randomized study with a long-term follow-up and the aim of this clinical study is to measure with qualitative and quantitative indicators the changes in cosmetic results, quality of…
- Conditions
- Breast Cancer, Mastectomy; Lymphedema, Quality of Life, Patient Satisfaction
- Trial name
- NCT04345081
- Testing
- Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction, Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgery
- Where
- Hungary
- Volunteers
- 110 people
- Sponsor
- National Institute of Oncology, Hungary
Breast Cancer, DCIS
Robotic Nipple Sparing Mastectomy with Immediate Reconstruction
Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct…
- Conditions
- Breast Cancer, DCIS, BRCA Mutation
- Trial name
- NCT06860217
- Testing
- Robotic Nipple-Sparing Mastectomy
- Where
- Italy
- Volunteers
- 24 people
- Sponsor
- European Institute of Oncology
Capsular Contracture Associated With Implant, Foreign-Body Reaction
Experimental and Clinical Investigation of the Implant Surface Roughness Reduction Effect on Early-stage Fibrosis
The goal of this single-center, randomised double-blinded trial is to compare the early stage fibrosis progression around conventional textured expander and the SmoothSilk® expander with reduced surface roughness in women…
- Conditions
- Capsular Contracture Associated With Implant, Foreign-Body Reaction, Wounds and Injuries, Tissue Expander Disorder
- Trial name
- NCT05648929
- Testing
- Patient Satisfaction Questionnaire, Pregnancy test, Blood draw
- Where
- Austria
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- Medical University Innsbruck