Clinical trials: Mastectomy and Breast Reconstruction
Breast Cancer, Ductal Carcinoma in Situ
The Ultrasound-guided Multiple-injection Costotransverse Block for Mastectomy and Primary Reconstructive Surgery.
The investigators have developed a novel ultrasound-guided nerve block indicated primarily for breast cancer surgery that mimic a thoracic paravertebral block (TPVB) - hitherto the internationally accepted regional anesthesia…
- Trial name
- NCT04248179
- Testing
- Ropivacaine injection, Saline 0.9%, Sufentanil and PONV prophylaxis
- Where
- Denmark
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Zealand University Hospital
Breast Cancer
Compare Outcomes Between Two Acellular Dermal Matrices
This study will evaluate the performance of Alloderm RTU medium (LifeCell) vs. Cortiva 1mm Allograft Dermis (RTI Surgical®, Inc.).
- Trial name
- NCT02891759
- Testing
- Alloderm RTU, Cortiva 1mm Allograft Dermis, Skin or nipple-sparing mastectomy
- Where
- United States
- Volunteers
- 320 people
- Sponsor
- Washington University School of Medicine
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
Surgical Site Infection, Surgical Complication
A Novel Surgical Irrigation Solution in Post-Mastectomy Reconstruction: Evaluating Xperience™
Goal of the Clinical Trial: The purpose of this clinical trial is to learn whether Xperience™ surgical irrigation solution is more effective than a standard dilute povidone-iodine solution in reducing surgical site infections…
- Conditions
- Surgical Site Infection, Surgical Complication, Implant Infection, Implant Complication
- Trial name
- NCT06649890
- Testing
- Xperience™ Advanced Surgical Irrigation, Dilute Povidone-Iodine
- Where
- United States
- Volunteers
- 224 people, healthy volunteers welcome
- Sponsor
- University of North Carolina, Chapel Hill
Breast Cancer, Breast Reconstruction
Autologous Fat Grafting for Total Breast Reconstruction in Irradiated Breast Cancer Patients
The goal of this clinical trial is to learn whether autologous fat transfer (AFT) is as effective and safe as Deep Inferior Epigastric Perforator (DIEP) flap breast reconstruction in irradiated breast cancer patients following…
- Conditions
- Breast Cancer, Breast Reconstruction, Breast Reconstruction After Mastectomy, Breast Cancer Radiation
- Trial name
- AFT-R (NCT07641985)
- Testing
- Autologous fat transfer, Deep inferior epigastric perforator flap
- Where
- Netherlands
- Volunteers
- 280 people
- Sponsor
- Maastricht University Medical Center
Breast Neoplasm Female, Complication of Radiation Therapy
Delayed-immediate Versus Delayed Breast Reconstruction in Breast Cancer Patients With Mastectomy and Radiation Therapy
In breast cancer patients treated by mastectomy and adjuvant post-mastectomy radiation therapy (PMRT) reconstruction is often delayed until 6 - 12 month after completion of chemotherapy and PMRT, due to high risk of complication.
- Conditions
- Breast Neoplasm Female, Complication of Radiation Therapy, Breast Implant; Complications
- Trial name
- NCT03730922
- Testing
- Delayed-immediate reconstruction, Delayed reconstruction
- Where
- 8 sites in Denmark
- Volunteers
- 590 people
- Sponsor
- Danish Breast Cancer Cooperative Group
Breast Cancer
The Effects of Radiation in Reconstructed Breasts
The primary objective of this study is to use LR imaging to evaluate the effects of adjuvant radiation therapy on reconstructed breasts.
- Trial name
- NCT01292772
- Testing
- contract-enhanced MRI, Unilateral Adjuvant Radiation Therapy
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Abramson Cancer Center at Penn Medicine
Breast Implant; Complications, Breast Implant Protrusion
Standard Silicone-based vs. B-Lite® Light Weight Breast Implant After Total Mastectomy and Radiotherapy for Breast Cancer
Reconstructive surgery with breast implants after total mastectomy for breast cancer is invariably related to several possible complications, such as atrophy of surrounding tissues, skin thinning, capsular contracture, wound…
- Conditions
- Breast Implant; Complications, Breast Implant Protrusion, Breast Cancer, Radiotherapy Side Effect
- Trial name
- BLITE-01 (NCT03737500)
- Testing
- B-Lite® light weight breast implant, Standard silicone-based breast implant
- Where
- Italy
- Volunteers
- 49 people
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
Breast Cancer
Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique
This trial is designed to compare robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with conventional open technique. It is a prospective randomized trial evaluating patients satisfaction
- Trial name
- NCT03440398
- Testing
- Robotic NSM, Open NSM
- Where
- Italy
- Volunteers
- 82 people
- Sponsor
- European Institute of Oncology
Breast Cancer, Breast Reconstruction
The Outcomes of Fat Grafting Combined With Latissimus Dorsi Muscle Flap for Delayed Breast Reconstruction After Mastectomy
The outcomes of fat grafting combined with latissimus dorsi muscle flap for delayed breast reconstruction after mastectomy
- Trial name
- NCT07331753
- Testing
- Fat grafting combined with latissimus dorsi muscle flap
- Where
- Egypt
- Volunteers
- 20 people
- Sponsor
- Sohag University
Breast Cancer, Breast Reconstruction
Incorporating Robotic Surgery in Both Mastectomy and DIEP Flap Reconstruction
A prospective study will be conducted to assess the outcomes of patients who underwent concurrent robotic-assisted mastectomy and robotic-assisted free DIEP flap harvest for breast reconstruction between March 2020 and June 25…
- Trial name
- NCT05945914
- Testing
- Oncoplastic Entirely Robot-Assisted Approach (OPERA)
- Where
- Taiwan
- Volunteers
- 9 people
- Sponsor
- Chang Gung Memorial Hospital
Breast Cancer
A Pilot Study to Evaluate Nipple-Areolar Complex (NAC) Sparing Mastectomy
The goal of this study is to study nipple-areolar complex (NAC) sparing mastectomy as an alternative procedure to the standard skin-sparing mastectomy for women who have breast cancer or are at high-risk for developing breast…
- Trial name
- NCT00539227
- Testing
- NAC Sparing Mastectomy, Questionnaire
- Where
- United States
- Volunteers
- 37 people
- Sponsor
- M.D. Anderson Cancer Center
Pain, Postoperative, Breast Cancer
Speeding Recovery From Pain and Opioid Use
Surgical treatment of breast cancer is associated with significant disability, and pain is often reported as a primary cause for declines in the ability to perform activities of daily living.
- Conditions
- Pain, Postoperative, Breast Cancer, Opioid Use, Surgery
- Trial name
- NCT03388814
- Testing
- Local infiltration of bupivacaine, Pectoralis Nerve block
- Sponsor
- Wake Forest University Health Sciences
Breast Cancer
Bupivacaine vs Placebo for Unilateral Mastectomy Surgical Site Post-operative Pain Control
The purpose of this study is to compare using FDA-approved bupivacaine (a numbing medicine), along with the usual medications for post-operative pain control to using the usual medications for postoperative pain control alone.
- Trial name
- NCT03351348
- Testing
- Bupivacaine, patient-reported pain scores, saline
- Where
- 7 sites in United States
- Volunteers
- 165 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Reconstruction, Radiation Dermatitis
Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients
The purpose of this study is to evaluate post-mastectomy breast skin blood supply (perfusion) after radiation therapy, and before and after fat grafting to the breast(s).
- Conditions
- Breast Reconstruction, Radiation Dermatitis, Radiation Fibrosis, Fat Grafting
- Trial name
- NCT04992650
- Testing
- Fat grafting
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Mayo Clinic
Breast Cancer, Invasive Breast Cancer
A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer
The purpose of this study to test an alternative treatment approach that involves giving participants radiotherapy before their mastectomy (preoperative radiotherapy) and performing immediate reconstruction surgery at the time of…
- Trial name
- NCT05412225
- Testing
- Pre-neoadjuvant radiotherapy (NART) biopsy, Neoadjuvant radiotherapy, Unilateral total mastectomy with axillary lymph node dissection
- Where
- 7 sites in United States
- Volunteers
- 60 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Breast Cancer, Pain, Postoperative
Botulinum Toxin A (Botox) in Tissue Expander Breast Reconstruction
Each year, the number of breast cancer survivors who choose post-mastectomy breast reconstruction keeps rising. Among women who elect to pursue breast reconstruction, approximately 75% will choose prosthetic breast…
- Conditions
- Breast Cancer, Pain, Postoperative, BRCA1 Mutation, BRCA2 Mutation
- Trial name
- NCT01591746
- Testing
- Botulinum Toxin Type A
- Where
- United States
- Volunteers
- 131 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
Breast Cancer
A Nationwide Multicenter, Single-arm, Retrospective Study of Delayed Endoscopic DTI-BR After Simple Mastectomy
This study is a nationwide multicenter, single-arm, retrospective study. The study aims to conduct a detailed analysis of operation-related parameters, aesthetic outcomes (e.g., BREAST-Q scores and Harris scores), and safety…
- Trial name
- DEDTI-BR (NCT07257003)
- Testing
- delayed endoscopic direct-to-implant breast reconstruction via axillary approach after simple mastectomy
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Du Zhenggui
Breast Reconstruction After Mastectomy
National, Multicenter PMS Study "Patient Reported Outcome" in Breast Reconstruction Following Mastectomy With TiLOOP Bra
This multicentre, non-randomised, observational clinical device investigation will be performed to obtain postmarketing information on the TiLOOP® Bra and in particular on the improvement of the patients' quality of life as well…
- Trial name
- PRO-BRA (NCT01885572)
- Testing
- TiLOOP Bra
- Where
- 8 sites in Germany
- Volunteers
- 267 people
- Sponsor
- Pfm Medical Mepro Gmbh
Mastectomy and Breast Reconstruction, Sexual Wellness
Sexual Well-being of Women Undergoing Mastectomy and Reconstruction
The study plans to collect data from patients on sexual well-being after mastectomy and immediate reconstruction by surveys. This data can support preoperative patient counselling and the prevention and care of adverse effects of…
- Trial name
- NCT07234461
- Testing
- Survey using a questionnaire.
- Where
- 19 sites in Italy
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- European Institute of Oncology