Clinical trials: Mastectomy With Reconstruction
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
Seroma, Breast Cancer
Seroma of the Mammary Gland
The study is designed as international, prospective, minimal interventional study in cooperation with EUBREAST e.V. (European Breast Cancer Research Association of Surgical Trialists).
- Conditions
- Seroma, Breast Cancer, Mastectomy, Breast Implant; Complications
- Trial name
- SerMa (NCT05899387)
- Testing
- Swap collection, Seroma punction, Blood sampling
- Where
- Germany
- Volunteers
- 2,000 people, healthy volunteers welcome
- Sponsor
- University Hospital Augsburg
Breast Cancer, BRCA1 Mutation
Depression and Body Image Distress Following Mastectomy With Reconstruction
Mastectomy is a major surgery that can have a profound effect on women's psychosocial wellbeing, including elevated depression and body image distress.
- Conditions
- Breast Cancer, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- NCT03428399
- Testing
- Psychosocial variables
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- Massachusetts General Hospital
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
Postoperative Pain, Postoperative Nausea and Vomiting
Pre-op Paravertebral Blocks to Decrease Post-op Pain Following Mastectomy With Immediate Tissue Expander (TE) Reconstruction
Primary Objective To determine if post-operative static pain scores differ between women undergoing bilateral mastectomy followed by bilateral immediate tissue expander reconstruction randomized either to ropivacaine- (treatment)…
- Conditions
- Postoperative Pain, Postoperative Nausea and Vomiting, Quality of Life
- Trial name
- NCT02161705
- Testing
- Ropivacaine, Saline
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Johns Hopkins University
Mastectomy, Breast Reconstruction
Mastectomy With Retention of the Nipple-areola Complex, Robot-assisted or Not, and / or Immediate or Seconday Reconstruction by Latissimus Dorsi Flap, Robot-assisted or Not.
Phase III, non-randomized, monocentric, observational, prospective trial. It is planned to recruit a total of 480 patients, including 240 patients receiving mastectomy with preservation of the nipple-areola complex and 240…
- Trial name
- RMR (NCT04457167)
- Testing
- Robot-assisted, Not robot-assisted surgery
- Where
- France
- Volunteers
- 480 people
- Sponsor
- Institut Paoli-Calmettes
Breast Cancer Female
Cosmetic Outcome, Patient-reported Outcomes, and Reconstruction-related Complications in Breast Cancer Women Treated With or Without Post-mastectomy Radiation Therapy
This study aim to investigate the breast reconstruction outcome after mastectomy with or without radiation therapy from the patient's point of view.
- Trial name
- NCT03523078
- Testing
- Breast reconstructive surgery
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Yonsei University
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
Patient Satisfaction
Unilateral Secondary Breast Reconstruction Using a Muscle-sparing Pedicled Dorsal Flap After Breast Cancer
The use of pedicled dorsal flaps sparing the latissimus dorsi muscle (TDAP and MSLD flap) is a well-described reconstruction method in breast reconstruction after breast cancer.
- Trial name
- RMSU-LDPEM (NCT06230250)
- Where
- France
- Volunteers
- 22 people
- Sponsor
- University Hospital, Brest
Mastectomy; Lymphedema, Breast Cancer
Polyurethan Versus Non-polyurethan Covered Implants in Combination With Radiotherapy
The purpose of this multicenter retrospective cohort study is to determine the effect of radiotherapy on capsular contraction and implant loss rates in patients undergoing prepectoral immediate implant-based breast reconstruction…
- Trial name
- PRExRT (NCT06747065)
- Testing
- Radiotherapy
- Where
- Switzerland
- Volunteers
- 1,000 people
- Sponsor
- University Hospital, Basel, Switzerland
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, 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
Breast Cancers, Mastectomy and Breast Reconstruction
Prediction of ICG for Skin Necrosis in Mastectomy With Immediate Reconstruction
Background Breast cancer represents 30 percent of newly diagnosed malignancies in female patients and is the leading cause of death in middle-aged women.
- Conditions
- Breast Cancers, Mastectomy and Breast Reconstruction, Skin Necrosis
- Trial name
- NCT06956443
- Volunteers
- 50 people
- Sponsor
- University Medical Center Groningen
Breast Cancer
Comparison of Breast Sensory Recovery Between Conventional and Endoscopic Nipple-Sparing Mastectomy Combined With Prepectoral Implant Reconstruction
This clinical trial aims to determine whether conventional surgery or endoscopic surgery results in better recovery of breast skin sensation in women with early-stage breast cancer undergoing nipple-sparing mastectomy with…
- Trial name
- NCT07372339
- Testing
- Conventional nipple-sparing mastectomy combined with prepectoral implant reconstruction, Endoscopic nipple-sparing mastectomy combined with prepectoral implant reconstruction
- Volunteers
- 170 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Ductal Breast Carcinoma, Invasive Breast Carcinoma
Hypofractionated Radiation Therapy After Mastectomy in Preventing Recurrence in Patients With Stage IIa-IIIa Breast Cancer
This randomized phase III trial studies how well hypofractionated radiation therapy works in preventing recurrence in patients with stage IIa-IIIa cancer who have undergone mastectomy.
- Conditions
- Ductal Breast Carcinoma, Invasive Breast Carcinoma, Lobular Breast Carcinoma, Medullary Breast Carcinoma
- Trial name
- NCT03414970
- Testing
- Radiation Therapy, Questionnaire Administration, Quality-of-Life Assessment
- Where
- 859 sites in United States, Canada
- Volunteers
- 898 people
- Sponsor
- Alliance for Clinical Trials in Oncology
Sensation Disorders, Sensation, Phantom
Prospective Study of Sensation and Satisfaction in Cancer and Transgender Mastectomy Patients
During breast surgery, sensory nerves are cut which may lead to reduced sensation and pain. Surgical reinnervation techniques have been developed with the aim of improving postoperative sensation by preserving the nerves and…
- Conditions
- Sensation Disorders, Sensation, Phantom, Pain, Postoperative, Pain, Chronic
- Trial name
- NCT06094257
- Testing
- Sensory testing
- Where
- 2 sites in United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Weill Medical College of Cornell University
Mammaplasty, Mastectomy
Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Micro Grafting
The primary objectives of this study is to determine whether use of a negative pressure external soft-tissue expansion system pre-operatively and post-operatively improves and secures graft survival in autologous fat micro…
- Conditions
- Mammaplasty, Mastectomy, Lumpectomy
- Trial name
- NCT00466765
- Testing
- Brava Autologous Fat Transfer System
- Where
- 2 sites in United States
- Volunteers
- 589 people, healthy volunteers welcome
- Sponsor
- Brava
Breast Carcinoma
Hypofractionated Post Mastectomy Radiation With Two-Stage Expander/Implant Reconstruction
Hypofractionated radiotherapy could provide more convenient treatment and had similar toxicities.However,reports of hypofractionated radiotherapy with two-stage expander/implant reconstruction are rare,Some studies have shown…
- Trial name
- NCT05045287
- Testing
- hypofractionated radiotherapy
- Where
- China
- Volunteers
- 57 people
- Sponsor
- Chinese Academy of Medical Sciences
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 Reconstruction, Breast Reconstruction Following Mastectomy
Post-market Prospective Clinical Study of Nagor Perle Mammary Implants
Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive being the primary indications. In order to confidently state safety and due to strict regulation on medical devices it is important to…
- Conditions
- Breast Reconstruction, Breast Reconstruction Following Mastectomy, Breast Revision, Breast Augmentation
- Trial name
- PERLE10PMCF (NCT06013514)
- Testing
- PERLE Sterile Smooth Opaque gel filled mammary implants
- Where
- United Kingdom
- Volunteers
- 60 people
- Sponsor
- GCA (Eurosilicone)