Status:
COMPLETED
Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study
Lead Sponsor:
Tiger Biosciences, LLC.
Conditions:
Breast Augmentation
Breast Reconstruction
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2018
Estimated Enrollment :
1788 Patients enrolled
Trial Details
Trial ID
NCT00905645
Start Date
November 1 2002
End Date
December 1 2018
Last Update
January 11 2024
Active Locations (1)
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1
Sientra, Inc.
Santa Barbara, California, United States, 93117