Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study
This trial is active, not recruiting.
|Conditions||breast augmentation, breast reconstruction, breast revision|
|Treatment||silimed gel-filled mammary implant|
|Start date||November 2002|
|End date||December 2017|
|Trial size||1788 participants|
|Trial identifier||NCT00905645, G010193|
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
time frame: 10 Years
Satisfaction determined by patients
time frame: 10 Years
Female participants at least 18 years old.
Inclusion Criteria Subjects are admitted into the study only if all of the following eligibility is true: - Female - Age limitation specific to the indication: - Primary Augmentation: Must be 18 years or older - Primary Reconstruction: No age limit - Revision: If original surgery was primary reconstruction, then no age limit. If original surgery was primary augmentation, then must be 18 years or older. - Adequate tissue available to cover implant(s) - Willingness to follow study requirements (informed consent form, follow-up visits) - Candidate for primary augmentation, primary reconstruction, or revision Exclusion Criteria Subjects are not eligible if any of the following criteria exist: - Advanced fibrocystic disease, considered to be pre-malignant without mastectomy - Inadequate or unsuitable tissue - Active infection in the body at the time of surgery - Pregnant or lactating - Medical condition that might result in unduly high surgical risk and/or significant postoperative complications, in the judgment of the Investigator - Use of drugs, including any drug that would interfere with blood clotting, that might result in high risk and/or significant postoperative complications - Demonstrated psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure - Determination by physical examination that the subject does have any connective tissue/autoimmune disorder - Existing carcinoma of the breast without accompanying mastectomy - MRI scan is prohibited because of implanted metal device, claustrophobia, or other condition.
|Official title||Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation|
Call for more information