Clinical trials: Mastectomy and Breast Reconstruction
Breast Reconstruction
Evaluation of the Safety and Effectiveness of ARTIA Reconstructive Tissue Matrix Breast Reconstruction (ADORA) in Adult Participants
The purpose of this study is to evaluate the safety and effectiveness of ARTIA in adult participants undergoing immediate, two-stage, implant-based breast reconstruction post-mastectomy.
- Trial name
- NCT06575192
- Testing
- ARTIA Reconstructive Tissue Matrix
- Where
- 23 sites in United States
- Volunteers
- 264 people
- Sponsor
- AbbVie
Breast Neoplasms, Mastectomy
Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection.
This study evaluates the impact of hyaluronic acid (HA) injection for nipple projection following mastectomy, as a complement to areola micropigmentation.
- Conditions
- Breast Neoplasms, Mastectomy, Mammaplasty, Nipple Disorder
- Trial name
- RECHIAL (NCT07008339)
- Testing
- Areola Micropigmentation, Hyaluronic Acid Filler Injection
- Where
- Spain
- Volunteers
- 138 people
- Sponsor
- Germans Trias i Pujol Hospital
Breast Cancer, Mastectomy; Lymphedema
Breast Reconstruction by Exclusive Lipomodulin : Feasibility, Evaluation of the Aesthetic Result and Quality of Life
Breast cancer is the leading female cancer in metropolitan France in terms of incidence and death. Among the therapeutic arsenal for the treatment of these cancers, surgery plays a very important role and even if a conservative…
- Trial name
- EXCLUFAT (NCT04625621)
- Where
- France
- Volunteers
- 118 people
- Sponsor
- Institut Cancerologie de l'Ouest
Opioid Use, Pain, Postoperative
Pain in Breast Surgery Intervention
This study will be a randomized control trial providing an educational component to study participants and a pre-operative and post-operative survey with a goal to show an improvement in pain control, decrease in narcotic use…
- Trial name
- NCT04058938
- Testing
- Educational handout instrument, Control
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Kansas Medical Center
Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer
Endoscopy/Robotic Assisted Nipple Skin Sparing Mastectomy
Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.
- Conditions
- Breast Cancer Early Stage Breast Cancer (Stage 1-3), Breast Cancer Non-invasive Breast Cancer, High Risk Breast Carcinoma
- Trial name
- NCT06823414
- Testing
- Video assisted mastectomy
- Where
- Spain
- Volunteers
- 126 people
- Sponsor
- Alejandra García-Novoa
Breast Cancer
International Prospective REgistry on Pre-pectorAl Breast REconstruction
This is an international multicenter prospective cohort study aimed at collecting data on breast reconstruction techniques with pre-pectoral implants after mastectomy for breast cancer.
- Trial name
- I-PREPARE (NCT05817175)
- Testing
- pre-pectoral breast reconstruction
- Where
- 11 sites in Argentina, Egypt and 7 more
- Volunteers
- 1,236 people
- Sponsor
- European Breast Cancer Research Association of Surgical Trialists
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
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
Delayed-Immediate Breast Reconstruction
The goal of this clinical research study is to evaluate a new two-stage approach (delayed-immediate reconstruction) to breast reconstruction in women who may require post-mastectomy radiation therapy.
- Trial name
- NCT00473122
- Testing
- Delayed-Immediate Breast Reconstruction
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- M.D. Anderson Cancer Center
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
Ductal Carcinoma in Situ - Category, Breast Cancer
Study to Assess Perfusion and Patient Satisfaction in Nipple-Areola Mastectomy With Immediate Reconstruction
The investigators hypothesize that nipple-areola skin sparing mastectomy (NASSM) performed through an inframammary incision has a superior blood supply relative to a lateral oblique incision.
- Conditions
- Ductal Carcinoma in Situ - Category, Breast Cancer, Prophylactic Mastectomy
- Trial name
- NASSM (NCT01969448)
- Testing
- Inframammary Fold Incision or Lateral Radial Incision, Lateral Radial Incision, Inframammary Fold Incision
- Where
- United States
- Volunteers
- 79 people
- Sponsor
- Washington University School of Medicine
Breast Cancer
Preoperative Nicotine Cessation for Women With Breast Cancer Recommended for Reconstruction
Close to 20% of cancer patients currently use nicotine products. Nicotine use in breast cancer patients is associated with poorer overall outcomes, including worsened survival and increased surgical complications.
- Trial name
- NCT06461650
- Testing
- Nicotine cessation program
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Florida
Breast Cancer, Chronic Pain
Persistent Pain After Reconstruction Following Mastectomy
A cross sectional study to determine the prevalence of persistent pain after reconstructive surgery after mastectomy for breast cancer, with a comparative analysis of a cohort treated with mastectomy without reconstruction.
- Trial name
- NCT01738048
- Testing
- Reconstruction
- Where
- Denmark
- Volunteers
- 1,352 people
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
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
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
Post-Mastectomy Chronic Pain Syndrome (Disorder)
Cryoablation for Post Mastectomy Pain Syndrome
This is a prospective, randomized, parallel-group, treatment control trial with cross-over options performed at four sites. The purpose of this study is to assess the efficacy and safety of cryoablation therapy for the treatment…
- Trial name
- NCT03293940
- Testing
- Cryoablation, Therapeutic Peripheral Nerve Block (tPNB) Injection
- Where
- 4 sites in United States
- Volunteers
- 35 people
- Sponsor
- Emory University
Breast Reconstruction, Mastectomy; Lymphedema
New Era of DIEP With Minimally Invasive Mastectomy
The free deep inferior epigastric artery perforator (DIEP) flap is the gold standard in autologous breast reconstruction. Asian patients often present with a smaller body mass index with relatively insufficient tissue.
- Trial name
- NCT06321549
- Testing
- The reference point of minimally invasive mastectomy procedure conducted
- Where
- Taiwan
- Volunteers
- 278 people
- Sponsor
- Chang Gung Memorial Hospital
Breast Cancer, Breast Reconstruction
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK Biodesign® Nipple Reconstruction Cylinder.
- Conditions
- Breast Cancer, Breast Reconstruction, Nipple Reconstruction
- Trial name
- NRC (NCT01216319)
- Testing
- Nipple reconstruction
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Cook Group Incorporated
Breast Reconstruction Following Mastectomy
Safety and Clinical Performance of a Biological Matrix Used in Implant-based Breast Reconstruction
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS Breast membranes used in breast reconstruction and to identify emerging risks in comparison to clinical data…
- Trial name
- NCT05031962
- Testing
- CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)
- Where
- 10 sites in France
- Volunteers
- 112 people
- Sponsor
- Meccellis Biotech
Breast Reconstruction Surgery
Tissue Reinforcement for Breast Reconstruction (TRBR) Pivotal Clinical Study (REDEFINE)
The GORE Tissue Reinforcement for Breast Reconstruction (TRBR) research study will look at breast reconstruction during mastectomy procedures.
- Trial name
- NCT06556654
- Testing
- TRBR Device
- Where
- 20 sites in United States
- Volunteers
- 180 people
- Sponsor
- W.L.Gore & Associates