Breast Reconstruction Clinical Trial
Official title:
Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation
NCT number | NCT00905645 |
Other study ID # | G010193 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2002 |
Est. completion date | December 2018 |
Verified date | September 2023 |
Source | Sientra, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.
Status | Completed |
Enrollment | 1788 |
Est. completion date | December 2018 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Sientra, Inc. | Santa Barbara | California |
Lead Sponsor | Collaborator |
---|---|
Sientra, Inc. |
United States,
Stevens WG, Calobrace MB, Alizadeh K, Zeidler KR, Harrington JL, d'Incelli RC. Ten-year Core Study Data for Sientra's Food and Drug Administration-Approved Round and Shaped Breast Implants with Cohesive Silicone Gel. Plast Reconstr Surg. 2018 Apr;141(4S Sientra Shaped and Round Cohesive Gel Implants):7S-19S. doi: 10.1097/PRS.0000000000004350. — View Citation
Stevens WG, Calobrace MB, Harrington J, Alizadeh K, Zeidler KR, d'Incelli RC. Nine-Year Core Study Data for Sientra's FDA-Approved Round and Shaped Implants with High-Strength Cohesive Silicone Gel. Aesthet Surg J. 2016 Apr;36(4):404-16. doi: 10.1093/asj/sjw015. — View Citation
Stevens WG, Harrington J, Alizadeh K, Berger L, Broadway D, Hester TR, Kress D, d'Incelli R, Kuhne J, Beckstrand M. Five-year follow-up data from the U.S. clinical trial for Sientra's U.S. Food and Drug Administration-approved Silimed(R) brand round and shaped implants with high-strength silicone gel. Plast Reconstr Surg. 2012 Nov;130(5):973-981. doi: 10.1097/PRS.0b013e31826b7d2f. — View Citation
Stevens WG, Harrington J, Alizadeh K, Broadway D, Zeidler K, Godinez TB. Eight-year follow-up data from the U.S. clinical trial for Sientra's FDA-approved round and shaped implants with high-strength cohesive silicone gel. Aesthet Surg J. 2015 May;35 Suppl 1:S3-10. doi: 10.1093/asj/sjv020. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Local Complications | Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years. | 10 Years | |
Secondary | Satisfaction Determined by Patients | Assessment of the effectiveness of Study Implants based on patient satisfaction using a 5-point scale where 1=strongly agree to 5= strongly disagree. The patient satisfaction measures through 10 years provided in the table below are based on questionnaire responses of "Strongly Agree" and "Agree." | 10 Years |
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