Clinical trials: Mastectomy and Breast Reconstruction
Breast Cancer
Financial Toxicity in Breast Cancer Surgery
The purpose of this study is to evaluate financial toxicity, or financial harm, in breast cancer patients. The study will follow patients throughout their cancer treatment.
- Trial name
- NCT05104632
- Where
- 2 sites in Canada
- Volunteers
- 630 people
- Sponsor
- McMaster University
Breast Reconstruction After Mastectomy, Breast Neoplasm
Post Market Clinical Follow Up to "Patient Reported Outcome" Using a Titanised Polypropylene Mesh (TiLOOP® Bra Pocket)
"PRO-Pocket" - International prospective multicentre Post Market Clinical Follow Up to "Patient reported outcome" in primary or secondary breast reconstruction after mastectomy using a titanised polypropylene mesh (TiLOOP® Bra…
- Conditions
- Breast Reconstruction After Mastectomy, Breast Neoplasm, Breast Cancer, Breast Diseases
- Trial name
- PRO-Pocket (NCT03868514)
- Testing
- TiLOOP® Bra Pocket
- Where
- 12 sites in Austria, Germany
- Volunteers
- 313 people, healthy volunteers welcome
- Sponsor
- pfm medical gmbh
Breast Cancer, Mastectomy
Post-Operative Outcomes of Low Thermal Dissection vs. Traditional Electrosurgery
Low thermal dissection devices have been introduced as a tool to improve surgical outcomes. PlasmaBlade, a low thermal dissection device, has shown to be associated with effective cutting, and significantly lower temperature than…
- Conditions
- Breast Cancer, Mastectomy, Perfusion; Complications, Hemostasis
- Trial name
- NCT03711916
- Testing
- PlasmaBlade 3.0S
- Where
- 2 sites in United States
- Volunteers
- 20 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
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, Postoperative Pain
Comparison of Pre-op and Post-op Pectoralis Nerve Block
The investigators will compare whether patients will have better pain control if they were to receive (PEC I/II block) before surgery or after mastectomy.
- Conditions
- Breast Cancer, Postoperative Pain, Anesthesia, Nerve Block
- Trial name
- NCT03653988
- Testing
- PEC I/II blocks by anesthesiologist - pre-operative, PEC I/II blocks by surgeon - intra-operative
- Where
- United States
- Volunteers
- 34 people
- Sponsor
- Melinda Seering
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, Unilateral
MIAMI Safe Surgery for Multiple Breast Cancers
Sometimes women have more than one breast cancer in the same breast at the same time. These women are usually offered a mastectomy (removal of that breast) and breast reconstruction.
- Trial name
- MIAMI (NCT03514654)
- Testing
- Mastectomy, Therapeutic Mammoplasty
- Where
- 7 sites in United Kingdom
- Volunteers
- 4 people
- Sponsor
- University College, London
Breast Cancer, Radiotherapy; Complications
Hypo Versus Conventional Fractionation in Reconstructed-Breast Cancer Mastectomy Patients
This randomized Phase III study aims to show major complication rate of hypofractionation radiation therapy is not inferior, compared to conventional fractionation radiation therapy in breast cancer patients undergoing mastectomy…
- Trial name
- NCT05253170
- Testing
- Hypofractionation, Conventional Fractionation
- Volunteers
- 622 people, healthy volunteers welcome
- Sponsor
- Seoul National University Bundang Hospital
Breast Carcinoma, Breast Disorder
Blossom Smart Expander Technology in Breast Reconstruction in Participants With Breast Cancer Undergoing Mastectomy
This phase 1 trial studies how well Blossom Smart Expander Technology works in breast reconstruction in participants with breast cancer undergoing mastectomy.
- Trial name
- NCT03657069
- Testing
- Blossom, Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Stanford University
Breast Cancer Invasive
Prospective, Multicentric Study Evaluating the Surgical Treatment by Mastectomy With Immediate Prosthetic Breast Reconstruction in Patients With Breast Cancer and Receiving Adjuvant Therapy by TomoTherapy +/-Chemotherapy.
Prospective, multicentric, non-randomized phase II study evaluating the surgical treatment by mastectomy with immediate prosthetic breast reconstruction in patients with breast cancer and receiving adjuvant therapy by TomoTherapy…
- Trial name
- MARTA (NCT03627988)
- Testing
- Mastectomy with Immediate prosthetic breast reconstruction and adjuvant tomotherapy
- Where
- 2 sites in France
- Volunteers
- 66 people
- Sponsor
- Institut Claudius Regaud
Breast Cancer
Breast Reconstruction With Acellular Dermal Matrix in the Setting of Breast Cancer Treatment
To evaluate breast reconstruction with implants using biological mesh (Strattice™) in the setting of breast cancer treatment.
- Trial name
- NCT02061527
- Testing
- Reconstruction with ADM., Skin or nipple sparing mastectomy, Reconstruction with implant
- Where
- 5 sites in Sweden, United Kingdom
- Volunteers
- 135 people
- Sponsor
- Karolinska University Hospital
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
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
Mastectomy, Breast Reconstruction
Sensation After Nipple Sparing Mastectomy and Breast Reconstruction With or Without Neurotized Free Tissue Transfer
Tissue Expander/Implant Reconstruction: The purpose of this study is to determine how and when nerve sensation to the breast skin returns after mastectomy.
- Trial name
- NCT03135392
- Testing
- Breast Reconstruction with Artificial Implant, Autologous Breast Reconstruction, Neurotization
- Where
- United States
- Sponsor
- Case Comprehensive Cancer Center
Skin Necrosis, Breast Reconstruction
B4P Trial - BLOOM43 for Preconditioning
The goal of this clinical trial is to evaluate the use of the Plexaa preconditioning device (BLOOM43) in patients undergoing reconstructive breast surgery for breast cancer.
- Conditions
- Skin Necrosis, Breast Reconstruction, Breast Surgery
- Trial name
- NCT07340632
- Testing
- BLOOM43
- Volunteers
- 60 people
- Sponsor
- Plexaa Ltd
Breast Neoplasms, Breast Carcinoma
Preoperative Radiation Therapy and Immediate Breast Reconstruction
The goal of this phase III randomized controlled trial (PRADAIIBE) is to assess if preoperative radiation therapy (Preop-RT) combined with immediate breast reconstruction (IBR) can safely improve both aesthetic and quality of…
- Conditions
- Breast Neoplasms, Breast Carcinoma, Breast Adenocarcinoma, Cancer
- Trial name
- PRADAIIBE (NCT06739655)
- Testing
- Preoperative radiotherapy, Postoperative radiotherapy, Immediate breast reconstruction
- Where
- 6 sites in Belgium
- Volunteers
- 180 people
- Sponsor
- Cancer Research Antwerp
Breast Cancer
Impact of Radiotherapy on Patients Undergoing DIEP Flap Breast Reconstruction
The investigators intend to undertake a study to investigate the effect of radiotherapy on deep inferior epigastric perforator flap reconstructions (DIEP).
- Trial name
- NCT03072316
- Testing
- 3D surface imaging, semi-structured interview, applanation tonometry
- Where
- United Kingdom
- Volunteers
- 300 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Breast Cancer
Delayed-Delayed Breast Reconstruction
The goal of this clinical research study is to learn if delayed-delayed breast reconstruction in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and result in fewer complications compared to the…
- Trial name
- NCT01256528
- Testing
- Delayed Breast Reconstruction
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- M.D. Anderson Cancer Center
Breast Cancer
Selective Intraoperative Administration of Local Anesthesia in Breast Reconstruction
Subjects are being asked to participate in this study because they will be undergoing unilateral (one) or bilateral (two) mastectomy surgery with immediate reconstruction involving insertion of a tissue expander.
- Trial name
- NCT02525718
- Testing
- Saline, 0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone
- Where
- United States
- Volunteers
- 47 people
- Sponsor
- Northwestern University
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