Clinical trials: Primary Breast Reconstruction
Breast Cancer
Primary Radiotherapy And DIEP flAp Reconstruction Trial
Many women with breast cancer now live for decades after their breast cancer treatment. In view of this, modern breast reconstruction surgery after mastectomy for breast cancer aims to reproduce as natural a breast shape as…
- Trial name
- PRADA (NCT02771938)
- Testing
- Radiotherapy before surgery
- Where
- United Kingdom
- Volunteers
- 33 people
- Sponsor
- Royal Marsden NHS Foundation Trust
Implant Based Breast Reconstruction
Post-market Surveillance Study to Evaluate the Quality of Life and the Safety and Effectiveness of the TIGR® Matrix After Reconstructive Breast Surgery
The goal of this observational study is to evaluate the quality of life of participants who have undergone implant-based breast surgery. This will be done using the BREAST-Q questionnaire.
- Trial name
- TIGR-Matrix (NCT06511167)
- Testing
- TIGR® Matrix
- Where
- 5 sites in Germany
- Volunteers
- 135 people
- Sponsor
- AWOgyn
Breast Reconstruction
Becker Continued Access Study
While Core Becker patient follow-up is being completed this Continued Access Study is designed to enroll patients at a limited rate per month to allow for continued physician and patient experience with the device.
- Trial name
- NCT01286870
- Testing
- Mentor Becker 25 Expander/Breast Implant, Mentor Becker 50 Expander/Breast Implant
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Mentor Worldwide, LLC
Wound Healing Disorder, Post-Surgical Complication
NovoX®Cup as Primary Dressing After Breast Reduction
Breast reduction is one of the most frequently performed plastic surgeries. Studies have shown that breast reduction surgery significantly improves the patients' suffering and leads to a better health-related quality of…
- Conditions
- Wound Healing Disorder, Post-Surgical Complication, Mammaplasty
- Trial name
- NCT06420323
- Testing
- Treatment with NovoX® Cup, Treatment with Omnistrip®
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- MOSS S.p.A.
Breast Cancer
Following the Use of Gel Prosethetics in Breast Reconstruction
Following placement of silicone breast prosthetics for reconstruction
- Trial name
- NCT00585884
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- University of California, Irvine
Breast Reconstruction
Study of the Mentor Becker Expander/Breast Implant in Subjects Who Are Undergoing Primary Breast Reconstruction
The purpose of this study is to determine the safety and effectiveness of the Becker Expander/Breast Implant in women who are undergoing primary breast reconstruction.
- Trial name
- NCT00750685
- Testing
- Mentor Smooth Becker 50 Expander/Breast Implant
- Volunteers
- 315 people
- Sponsor
- Mentor Worldwide, LLC
Breast Implants
Study of the Safety and Effectiveness of Motiva Implants®
This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.
- Trial name
- NCT03579901
- Testing
- Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
- Where
- 29 sites in United States, Germany and 1 more
- Volunteers
- 800 people, healthy volunteers welcome
- Sponsor
- Motiva USA LLC
Breast Neoplasm Female, Breast Reconstruction
Axillary Versus Primary Breast Approach for Second-stage Breast Reconstruction
The goal of this clinical trial is to compare the safety of axillary or primary breast approach for second-stage operation in expander-implant breast reconstruction for breast cancer patients.
- Conditions
- Breast Neoplasm Female, Breast Reconstruction, Wound Complication
- Trial name
- AvBSR (NCT05600153)
- Testing
- implant exchange operation
- Where
- China
- Volunteers
- 136 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
Breast Reconstruction, Revision Breast Reconstruction
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
The study will evaluate the long-term safety and effectiveness with the Mentor MemoryGel® Larger Size Ultra High Profile (UHP-L) Breast Implants.
- Trial name
- Athena (NCT02724371)
- Testing
- Mentor Larger Size MemoryGel Ultra High Profile Breast Implant
- Where
- 30 sites in United States
- Volunteers
- 400 people
- Sponsor
- Mentor Worldwide, LLC
Primary Breast Augmentation, Primary Breast Reconstruction
Memory Gel and Shape Combined Cohort
The purpose of this study is to collect additional post-approval clinical data on the long-term performance of MemoryShape and MemoryGel Breast Implants, as indicated for primary or revisional breast augmentation and primary or…
- Conditions
- Primary Breast Augmentation, Primary Breast Reconstruction, Revision Breast Augmentation, Revision Breast Reconstruction
- Trial name
- Glow (NCT02919592)
- Testing
- MemoryShape® Breast Implants, MemoryGel® Breast Implants, Other Aesthetic Surgery
- Where
- 78 sites in United States
- Volunteers
- 3,603 people
- Sponsor
- Mentor Worldwide, LLC
Breast Augmentation, Breast Reconstruction
Mentor Siltex® Contour Profile Gel Mammary Prosthesis Clinical Trial
The Contour Profile Gel Study is designed to demonstrate safety and effectiveness of Mentor's Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- CPG (NCT00812097)
- Testing
- Mentor Siltex® Contour Profile Gel Mammary Prosthesis
- Where
- United States
- Volunteers
- 955 people
- Sponsor
- Mentor Worldwide, LLC
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 Reconstruction, Breast Augmentation
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Reconstruction, Breast Augmentation, Breast Revision
- Trial name
- NCT00753922
- Testing
- Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface
- Where
- United States
- Volunteers
- 1,008 people
- Sponsor
- Mentor Worldwide, LLC
Mammoplasty Patient
Evaluation of Perforator Phase Contrast Angiography in Developing Surgery Plans for Patients With Breast Cancer Undergoing Breast Reconstruction With Free-Flap Methods After Mastectomy
This phase II trial studies how well an imaging technique called perforator phase contrast angiography (pPCA) works in developing surgery plans for patients with breast cancer undergoing breast reconstruction after breast removal…
- Trial name
- NCT04063410
- Testing
- Angiography, MRI-Based Angiogram, Quality-of-Life Assessment
- Where
- United States
- Sponsor
- University of Cincinnati
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 Augmentation, Breast Reconstruction
CPG Styles Study: A Study of the Safety of the Contour Profile Gel Breast Implants (CPG Styles Study)
The CPG Styles Study is designed to demonstrate the safety of different styles of Mentor's Contour Profile Gel (CPG) breast implants in women who are undergoing primary augmentation, primary reconstruction, or revision.
- Conditions
- Breast Augmentation, Breast Reconstruction, Breast Revision
- Trial name
- NCT01959880
- Testing
- The Contour Profile Gel (CPG) breast implants
- Where
- United States
- Volunteers
- 1,891 people, healthy volunteers welcome
- Sponsor
- Mentor Worldwide, LLC
Breast Cancer, Lipofilling
Evaluation of the Efficacy and Safety of Using Platelet-rich Fibrin (PRF)-Based Lipobolus for the Immediate Reconstruction of Defects After Breast-conserving Resection for Breast Cancer (Minimally Invasive Primary Immediate Grafting)
The goal of this clinical trial is to learn if a special type of fat graft, made by mixing a person's own fat with platelet-rich fibrin (PRF), works to fix breast shape defects after cancer surgery.
- Conditions
- Breast Cancer, Lipofilling, Fat Graft, Platelet Rich Plasma
- Trial name
- MINIPIG (NCT07658170)
- Testing
- Lipobolus (Autologous Fat + Platelet-Rich Fibrin+Calcium chloride)
- Where
- Russia
- Volunteers
- 30 people
- Sponsor
- The Leningrad Regional Clinical Hospital