Clinical trials: Mastectomy, Subcutaneous
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 - Ductal Carcinoma in Situ (DCIS), Breast Cancer
Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer
This single-center prospective study will evaluate the feasibility and safety of endoscopic nipple-sparing mastectomy (E-NSM) performed through a single axillary incision in selected women with breast cancer undergoing…
- Trial name
- Mini-B (NCT07507890)
- Testing
- Endoscopic Nipple-Sparing Mastectomy (E-NSM)
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- Fondazione del Piemonte per l'Oncologia
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
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 Reconstruction Following Mastectomy
Does Nerve Grafting Improve Sensation After Nipple-Sparing Mastectomy With Implant Reconstruction?
The goal of this clinical trial is to learn if adding an allogeneic (donor) nerve graft during breast reconstruction can improve recovery of breast and nipple sensation in women undergoing bilateral nipple-sparing mastectomy with…
- Trial name
- NCT07819357
- Testing
- Allogeneic Nerve Grafting
- Where
- 3 sites in United States
- Volunteers
- 45 people
- Sponsor
- Endeavor Health
Breast Cancer
Preoperative Evaluation of 3D Reconstruction Tool for Nipple-sparing Mastectomy
The goal of this clinical study is to explore whether preoperative application of 3D reconstruction tool can reduce the occurrence of ischemic complications in the flap and nipple areola complex after surgery.
- Trial name
- NCT06071234
- Testing
- 3D reconstruction technology
- Where
- China
- Volunteers
- 126 people
- Sponsor
- Guangdong Provincial People's Hospital
Breast Cancer, Breast Neoplasms, Breast Reconstruction
Evaluation of Wellbeing and Patient Reported Outcomes After Open vs Robotic Mastectomy With DIEP Reconstruction
Nipple-sparing mastectomy (NSM) preserves the nipple-areolar complex (NAC) and is associated with improved cosmetic outcomes, body image, and patient satisfaction compared with more ablative techniques.
- Conditions
- Breast Cancer, Breast Neoplasms, Breast Reconstruction, DIEP Flap Breast Reconstruction, Robotic Surgery
- Trial name
- REBORN (NCT07230535)
- Testing
- Robotic Assisted Nipple Sparing Mastectomy, Standarding Open Nipple Sparing Mastectomy
- Where
- Ireland
- Volunteers
- 250 people
- Sponsor
- Beaumont Hospital
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
Mastectomy, Gender Affirmation Surgery
The Role of Amnion Membrane Allografts in Nipple Preservation
The overall objective of this proposal is to conduct a randomized-controlled study to determine whether treatment with dehydrated human amnion/chorion membrane (dHACMs) allografts can improve NAC viability in patients undergoing…
- Conditions
- Mastectomy, Gender Affirmation Surgery, Nipple Sparing Mastectomy, Prophylactic Mastectomy
- Trial name
- AmnioFix (NCT06073808)
- Testing
- AmnioFix dehydrated Human Amnion/Chorion Membrane Allograft, Control Device
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Stanford University
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
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
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
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 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
Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.
- Trial name
- NCT03892980
- Testing
- Nipple-Sparing Mastectomy
- Where
- 6 sites in United States
- Volunteers
- 145 people
- Sponsor
- Intuitive Surgical
Breast Cancer
Oncologic Outcomes of Minimal Access Nipple-sparing Mastectomy Compared With Conventional Approach in Breast Cancer
In this study the investigators investigate the oncological outcomes of minimal access nipple sparing mastectomy compared with conventional nipple sparing mastectomy for the treatment of breast cancer
- Trial name
- NCT07069803
- Volunteers
- 1,129 people
- Sponsor
- Changhua Christian Hospital
Endoscopic Video-assisted Nipple-sparing Mastectomy, Breast Surgery
Endoscopic Video-Assisted Nipple-Sparing Mastectomy
Endoscopic video-assisted nipple-sparing mastectomy (E-NSM) is an advancement in minimally invasive breast surgery designed to reduce surgical trauma and improve cosmetic outcomes while maintaining strict oncologic safety.
- Conditions
- Endoscopic Video-assisted Nipple-sparing Mastectomy, Breast Surgery, Breast Cancer
- Trial name
- EVA (NCT07579117)
- Testing
- Endoscopic video-assisted nipple-sparing mastectomy (E-NSM)
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- European Institute of Oncology
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
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 Reconstruction, Breast Cancer Patients
Autologous Nerve Graft Breast Reconstruction Neurotization
The goal of this observational study is to learn about the improvement of quality of life in accordance with breast neurotization in breast cancer patients. The patient-reported outcome was assessed by questionnaire.
- Conditions
- Breast Reconstruction, Breast Cancer Patients, Nipple-sparing Mastectomy
- Trial name
- NCT06629012
- Testing
- Breast reconstruction with neurotization, Breast reconstruction without neurotization
- Where
- Taiwan
- Volunteers
- 250 people
- Sponsor
- Chang Gung Memorial Hospital