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Breast Augmentation Clinical Trials and Studies

The information provided on this page comes from ClinicalTrials.gov.



We have received a number of e-mails with questions about breast augmentation clinical trials and studies. The U.S. National Institutes of Health, Department of Health and Human Services, through its National Library of Medicine, has created ClinicalTrials.gov website to provide patients, family members, and members of the public current information about clinical research studies. ClinicalTrials.gov contains summary information about clinical trials being conducted throughout the US and in many countries throughout the world.





On Nov 12, 2007 we have found in the ClinicalTrials.gov database two clinical trials directly related to breast augmentation and still recruiting new participants:

Memorygel Postapproval Study For Mentor Silicone Gel-Filled Breast Implants (ClinicalTrials.gov Identifier: NCT00495534)


Conditions: Postoperative Complications; Cicatrix
Intervention: Device: Mentor MemoryGel Silicone Gel-filled breast implants

Breast Reconstruction and Augmentation With Brava Enhanced Autologous Fat Mico Grafting (ClinicalTrials.gov Identifier: NCT00466765)
Conditions: Mammaplasty; Mastectomy; Lumpectomy
Intervention: Procedure: Autologous Fat Grafting to the Breast


Understanding Clinical Trials

Choosing to participate in a clinical trial is an important personal decision. The following frequently asked questions provide detailed information about clinical trials. In addition, it is often helpful to talk to a physician, family members, or friends about deciding to join a trial. After identifying some trial options, the next step is to contact the study research staff and ask questions about specific trials.

What is a clinical trial?

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

Why participate in a clinical trial?

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

Who can participate in a clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

What are the different types of clinical trials?

Treatment trials test experimental treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.

Prevention trials look for better ways to prevent disease in people who have never had the disease or to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.

Diagnostic trials are conducted to find better tests or procedures for diagnosing a particular disease or condition.

Screening trials test the best way to detect certain diseases or health conditions.

Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of life for individuals with a chronic illness.

Who sponsors clinical trials?

Clinical trials are sponsored or funded by a variety of organizations or individuals such as physicians, medical institutions, foundations, voluntary groups, and pharmaceutical companies, in addition to federal agencies such as the National Institutes of Health (NIH), the Department of Defense (DOD), and the Department of Veteran's Affairs (VA). Trials can take place in a variety of locations, such as hospitals, universities, doctors' offices, or community clinics.



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