Clinical trials: Breast Implants
Breast Cancer
Association of Breast Reconstruction Method With Long-term Risk of Psychiatric Disorders
Female breast cancer patients who underwent total mastectomy followed by breast reconstruction
- Trial name
- NCT06981689
- Volunteers
- 24,930 people
- Sponsor
- Samsung Medical Center
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
Clinical and Economic Outcomes With the Use of SERI® Surgical Scaffold in Direct-to-implant Breast Reconstruction
The objective of this study is to prospectively observe clinical and economic outcomes with the use of SERI® in direct-to-implant breast reconstruction.
- Trial name
- NCT02033590
- Testing
- Biodegradable (purified) surgical silk scaffold
- Sponsor
- Sofregen Medical, Inc.
Breast Cancer
Hypofractionated Radiation Fractionation in Breast Cancer Patients With Implant-Based Reconstruction
It is a randomized trial to assess the safety and efficacy between hypofractionation radiation and conventional radiation in women who have undergone mastectomy and immediate breast reconstruction.
- Trial name
- HFIBR (NCT06830083)
- Testing
- Hypofractionated Radiation Therapy, Conventional fraction radiotherapy
- Where
- China
- Volunteers
- 840 people
- Sponsor
- The First Affiliated Hospital with Nanjing Medical University
Contraception, Breastfeeding
Immediate Postpartum Contraceptive Implant Placement and Breastfeeding Success in Women at Risk for Low Milk Supply: A Non-inferiority Trial
The investigators goal is to measure the impact of timing of postpartum contraceptive implant insertion on breastfeeding success and duration and to explore women's experiences with and attitudes towards contraceptive and…
- Conditions
- Contraception, Breastfeeding, Postpartum Contraception
- Trial name
- NCT02866279
- Testing
- Etonogestrel Contraceptive Implant
- Where
- United States
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- Montefiore Medical Center
Breast Cancer
Biological Matrices Versus Synthetic Meshes
In this feasibility study, 60 women undergoing reconstruction will be randomly allocated to receive biological or synthetic mesh and followed for 6 months.
- Trial name
- BIOSYM (NCT05449691)
- Testing
- One-stage immediate breast reconstruction
- Where
- 5 sites in United Kingdom
- Volunteers
- 60 people
- Sponsor
- University Hospitals of Derby and Burton NHS Foundation Trust
Genetic Predisposition, Breast Cancer
Pre Pectoral Implant for Immediate Breast Reconstruction Using Single Port Endoscopy in Prophylactic Indication
Implant-based reconstruction is currently the most common choice for mastectomy reconstruction. Whatever the choice of mastectomy incision, a scar remains on or near the breast volume.
- Trial name
- MRIMOP (NCT03838549)
- Testing
- Prophylactic mastectomy with immediate breast reconstruction
- Where
- France
- Volunteers
- 20 people
- Sponsor
- University Hospital, Montpellier
Breast Reconstruction
Direct to Implant Breast Reconstruction Based Pre- or Retropectoral
The purpose of this study is to examine different outcomes of breast reconstruction in women who are treated for breast cancer with skin sparing mastectomy and subsequently a primary implant based reconstruction by one of two…
- Trial name
- NCT03143335
- Testing
- Retropectoral immediate breast reconstruction, Prepectoral immediate breast reconstruction
- Where
- 3 sites in Denmark, Norway
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Odense University Hospital
Breast Implant Revision
LTFU of PCL Breast Scaffolds Used in 2021-BRV-004
The objective of this study is to assess the long-term safety and performance of the PCL Breast Scaffold in women who previously underwent breast silicone implant revision and received the PCL Breast Scaffold combined with…
- Trial name
- NCT07383012
- Where
- Australia
- Volunteers
- 19 people
- Sponsor
- BellaSeno Pty Ltd
Breast Cancer, Breast Reconstruction
Single-Stage Prepectoral Placement of Textured Implants Using a Polyester Mesh Endoprostheses With Fluoropolymer Coating in Patients With Breast Cancer
This study aims to evaluate the efficacy of using a polyester mesh endoprosthesis with a fluoropolymer coating in reducing postoperative complications, particularly protrusions, following subcutaneous mastectomy with simultaneous…
- Conditions
- Breast Cancer, Breast Reconstruction, Coated Materials, Reconstruction Breast Surgery
- Trial name
- FluoropolyMesh (NCT07185334)
- Testing
- Subcutaneous mastectomy using a fluoropolymer-coated polyester mesh endoprosthesis with simultaneous prepectoral placement of textured implants., Subcutaneous mastectomy with simultaneous prepectoral placement of textured implants.
- Where
- Russia
- Volunteers
- 100 people
- Sponsor
- Saint Petersburg State University, Russia
Surgical Site Infection
Dressing Wear Time After Breast Augmentation With Prosthesis
This study was designed to determine whether the duration of dressing wear following augmentation mammaplasty influence skin colonization and eventually surgical site infections rates.
- Trial name
- NCT01553604
- Testing
- augmentation mammaplasty
- Where
- Brazil
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Daniela Francescato Veiga
Breast Reconstruction With Silicone Implants
McGhan Medical Silicone-Filled Breast Implant Adjunct Study
This study will collect 5 year data about any possible health problems associated with breast implants. This data will be used to help see if the implants are both safe and effective.
- Trial name
- NCT00581984
- Where
- United States
- Volunteers
- 1,016 people
- Sponsor
- Memorial Sloan Kettering Cancer Center
Bilateral Breast Augmentation
Evaluation of the Safety and Performance of SYMATESE AESTHETICS ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants in the Breast Augmentation
The purpose of this study is to collect clinical data to evaluate the safety and performance of ESTYME® MATRIX Round microtextured breast implants in patients who receive these silicone gel-filled implants as part of their breast…
- Trial name
- EMMA (NCT05336526)
- Testing
- ESTYME® MATRIX Round Microtextured Silicone Gel-Filled Breast Implants
- Where
- 6 sites in France
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Symatese Aesthetics
Breast Augmentation, Breast Reconstruction
A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
At a national level of 15%, the reoperation rate following augmentation mammaplasty is too high. We are conducting a survey to examine the pre-operative methods by which plastic surgeons determine implant volume, size, shape and…
- Trial name
- NCT00684749
- Where
- United States
- Volunteers
- 142 people
- Sponsor
- University of Minnesota
Breast Neoplasms
SurgiMend® vs. Strattice™ in Direct to Implant Breast Reconstruction- A Prospective Randomized Trial
An increasing number of women undergo an immediate breast reconstruction, where the mastectomy and the breast reconstruction are performed in the same surgery.
- Trial name
- NCT02521623
- Testing
- SurgiMend® Acellular Dermal Matrix, Strattice™ Acellular Dermal Matrix
- Where
- Denmark
- Volunteers
- 60 people
- Sponsor
- Aarhus University Hospital
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
Breast Cancer, Implant Breast Reconstruction
Neoadjuvant Radiotherapy and Immediate Implant-Based Breast Reconstruction
Neoadjuvant radiotherapy(NART) followed by mastectomy and immediate DIEP flap reconstruction is feasible and technically safe. However, reports of NACT followed immediate implant-based breast reconstruction are rare.
- Conditions
- Breast Cancer, Implant Breast Reconstruction, Neoadjuvant Radiotherapy
- Trial name
- NCT05992870
- Testing
- Neoadjuvant radiotherapy
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Hubei Cancer Hospital
Breast Cancer
A Comparative Study of Delayed Endoscopic DTI and Latissimus Dorsi ±Impalnt Reconstruction Post-Mastectomy
Breast cancer is the most common malignancy in women. In 2022, China saw about 357,200 new cases and 75,000 deaths, accounting for 15.59% and 7.94% of all new cancer cases and cancer-related deaths, respectively.
- Trial name
- DELTI (NCT07757074)
- Testing
- Surgery options
- Where
- China
- Volunteers
- 268 people
- Sponsor
- Du Zhenggui
Breast Cancer
Evaluating the Effectiveness and Outcomes of Silicone Breast Prosthetics
This trial will evaluate the outcome of placement of silicone breast prosthetics.
- Trial name
- NCT00594490
- Where
- United States
- Volunteers
- 132 people
- Sponsor
- University of California, Irvine
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