Status:
COMPLETED
Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses
Lead Sponsor:
Mentor Worldwide, LLC
Conditions:
Breast Reconstruction
Breast Augmentation
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 reco...
Detailed Description
Silicone gel-filled breast implants were introduced in the early sixties and were in wide-scale distribution by the time the Medical Device Amendments to the Food Drug and Cosmetic Act was passed in 1...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
1008 Patients enrolled
Trial Details
Trial ID
NCT00753922
Start Date
September 1 2000
End Date
June 1 2012
Last Update
April 16 2014
Active Locations (1)
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1
Mentor Worldwide, LLC
Santa Barbara, California, United States, 93111