Breast Reconstruction Clinical Trial
Official title:
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses in Patients Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction or Revision
Verified date | March 2014 |
Source | Mentor Worldwide, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The Core Gel Study is designed to demonstrate safety and effectiveness of Mentor's Round
Low-Bleed Silicone Gel-filled Mammary Prostheses in women who are undergoing primary
augmentation, primary reconstruction, or revision. Safety information on the rate of
capsular contracture, rupture, and infection will be collected, and used to help determine
device safety.
Approximately 1000 patients at centers across the United States will be enrolled in this
research study. These patients will be implanted with silicone breast prostheses and
monitored for 10 years to collect information on risks associated with the implant surgery
as well as changes in the way these patients feel about themselves.
Status | Completed |
Enrollment | 1008 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Subject is Genetic female and at least 18 years old - A candidate for: - Primary breast augmentation (for post-lactational mammary involution or general breast enlargement) - Primary breast reconstruction (for cancer, trauma, surgical loss of breast or congenital deformity) - Revision surgery (previous augmentation or reconstruction with silicone-filled or saline-filled implants) - Signs the Informed Consent - Agrees to follow the procedures for explant analysis - Agrees to comply with follow-up procedures, including returning for all follow-up visits Exclusion Criteria: - Patient is pregnant - Has nursed a child within three months of study enrollment - Been implanted with any silicone implant other than breast implants (e.g. silicone artificial joints or facial implants) - Confirmed diagnosis of the following rheumatic diseases or syndromes: SLE, Sjogren's syndrome, scleroderma, polymyositis, or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infections arthritis, spondylarthropathies, any other inflammatory arthritis, osteoarthritis, fibromyalgia, or chronic fatigue syndrome - Currently has a condition that could compromise or complicate wound healing (except reconstruction patients) - Patient in Augmentation cohort and has diagnosis of active cancer of any type - Infection or abscess anywhere in the body - Demonstrates tissue characteristics which are clinically incompatible with implant (e.g. tissue damage resulting from radiation, inadequate tissue, or compromised vascularity) - Possesses any condition, or is under treatment for any condition which, in the opinion of the investigator and/or consulting physicians(s), may constitute an unwarranted surgical risk - Anatomic or physiologic abnormality which could lead to significant postoperative adverse events - Demonstrates characteristics that are unrealistic/unreasonable with the risks involved with the surgical procedure - Premalignant breast disease without a subcutaneous mastectomy - Untreated or inappropriately treated breast malignancy, without mastectomy - Implanted metal or metal devices, history of claustrophobia or other condition that would make a MRI scan prohibitive |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Mentor Worldwide, LLC | Santa Barbara | California |
Lead Sponsor | Collaborator |
---|---|
Mentor Worldwide, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Any Reoperation | Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest. | 10 years | Yes |
Primary | Overall Mean Change in Circumferential Chest Size | Change in Chest Size was calculated by subtracting the chest circumference prior to surgery from the chest circumference measured at the end of the study | Change from baseline to 10 years post-baseline | No |
Primary | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Baker III, IV Capsular Contracture | Baker III was identified as "firm with visible distortion" and Baker IV was identified as "obvious spherical distortion". Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest. | 10 Years | Yes |
Primary | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Infection | Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest. | 10 Years | Yes |
Primary | 10-Year Kaplan-Meier Estimated Cumulative Incidence Rate of Occurrence of Explantation With or Without Replacement | Time of occurrence calculated as the number of days from the date of the implant procedure to the onset date of the event. Patients were censored as of the date of their last office visit, the 120 month time point, or the date of explantation of all initial study devices, whichever was earliest. | 10 Years | Yes |
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