Clinical trials: Nipple Sparing Mastectomy
Gynecomastia, Surgical Incision
Modified Benelli Procedure For Subcutaneous Mastectomy
The study included 150 patients with gynecomastia (Grade II and III) for the period between January 2010 and January 2016 who attended private hospitals and Al- Kindy Teaching Hospital.
- Trial name
- NCT04063722
- Testing
- modified Benelli procedure
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Al-Kindy College of Medicine
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 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
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
Cold Dissection Versus Electrocautery Dissection in Endoscopic Nipple-Sparing Mastectomy and Immediate Implant-Based Reconstruction: A Randomized Controlled Trial
The purpose of this study is to analyze whether cold dissection can decrease the rate of ischemia necrosis and other complications and then increase the aesthetic outcomes compared to electrocautery.
- Trial name
- NCT06024187
- Testing
- Cold dissection, Electrocautery Dissection
- Where
- China
- Volunteers
- 566 people
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 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
Breast Cancer Female, Breast Cancer
Robotic vs. Open NSM for Early Stage Breast Cancer
This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.
- Conditions
- Breast Cancer Female, Breast Cancer, Breast Cancer, Early-Onset, Breast Disease
- Trial name
- SP NSM (NCT05720039)
- Testing
- Robotic NSM, Open NSM
- Where
- 15 sites in United States
- Volunteers
- 204 people
- Sponsor
- Intuitive Surgical
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
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 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 Reconstruction, Breast Cancer
Successful Microsurgical Breast Reconstruction in Minimally Invasive Mastectomy
A retrospective chart review will be conducted to identify patients who received breast reconstruction surgery with DIEP flaps by a single plastic surgeon in one medical center between November 2018 and July 2022.
- Trial name
- NCT05943873
- Where
- Taiwan
- Volunteers
- 63 people
- Sponsor
- Chang Gung Memorial Hospital
Breast Cancer, Mastectomy
Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer
The goal of this clinical trial is to learn if the AMADeuS care pathway is as safe as usual hospital care and works as well for pain control in women having mastectomy with immediate prepectoral breast reconstruction.
- Conditions
- Breast Cancer, Mastectomy, Prepectoral Breast Reconstruction, ERAS Programmes
- Trial name
- AMADeuS (NCT07510698)
- Testing
- AMADeuS Perioperative Pathway, Usual Perioperative Care
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- University of Rome Tor Vergata
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
Malignant Breast Neoplasm
A Study to Compare the Effectiveness of Two Types of Ultrasound Technologies in Women Who Have Had Breast Cancer
This clinical trial evaluates automated breast ultrasound (ABUS) and handheld ultrasound (HHUS) for the screening of women who have undergone breast reconstruction after breast cancer.
- Trial name
- NCT05408260
- Testing
- Ultrasonography, Automated Breast Ultrasound
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Thomas Jefferson University
Breast Cancer
Evaluation of the Safety and Efficacy of Single-Port Robot-Assisted Endoscopic Breast-Conserving Surgery and Nipple-sparing Matectomy With Reconstruction in Early-Stage Breast Cancer Patients
This study is testing a new, less invasive way to perform breast cancer surgery using a single-port robotic system (a robot-assisted surgical tool made in China, called the Shurui SR-ENS-600).
- Trial name
- NCT07781163
- Testing
- single-port robot-assisted surgery
- Volunteers
- 30 people
- Sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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/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
Genetic Predisposition, Breast Cancer
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume.
- Trial name
- MRIMOP (NCT03838549)
- Testing
- Prophylactic mastectomy with immediate breast reconstruction
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Montpellier
Prophylactic Nipple Sparing Mastectomy (NSM)
Post Market Clinical Follow-up Study on da Vinci® Robotic-assisted Prophylactic Nipple Sparing Mastectomy With Breast Reconstruction
The objective of this study is to collect post-market clinical safety and performance data on the robotic assisted prophylactic Nipple Sparing Mastectomy (R-NSM) surgery performed with the da Vinci Xi/X Surgical System as part of…
- Trial name
- PREVENT (NCT05251285)
- Testing
- Nipple-Sparing Mastectomy
- Where
- 2 sites in France, Italy
- Volunteers
- 7 people
- Sponsor
- Intuitive Surgical