Study of the Safety and Effectiveness of Motiva Implants®
- Conditions
- Breast Implants
- Interventions
- Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
- Registration Number
- NCT03579901
- Lead Sponsor
- Motiva USA LLC
- Brief Summary
This study evaluates the safety and effectiveness Motiva Implants® in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.
- Detailed Description
Prospective, Single Arm, Multicenter Study. Following FDA approval, follow-up data will continue to be collected for all cohorts on adverse events, reoperations, patient satisfaction, physician satisfaction and quality of life for a total of 10 years.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 800
Not provided
- Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2 without a previous bilateral mastectomy or an untreated cancer of any type.
- Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration compromised vascularity, history of compromised wound healing).
- Has an abscess or infection.
- Is pregnant or nursing or has had a full-term pregnancy or lactated within 6 months of enrollment.
- Is taking any drugs that would interfere with blood clotting, or that might result in elevated risk and or significant postoperative complications.
- Has any medical condition such as obesity (BMI ≥ 40), diabetes, autoimmune disease, chronic lung or severe cardiovascular disease that might result in unduly high surgical risk and or significant postoperative complications.
- Has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others.
- Has any condition that impedes the use of magnetic resonance imaging (MRI) including implanted metal device, claustrophobia or other conditions that would make MRI scan prohibited.
- Has a history of psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure.
- Has been implanted with any non-FDA approved breast implant.
- Has been implanted with any silicone implant other than breast implants.
- HIV positive (based on medical history).
- Has been diagnosed with anaplastic large cell lymphoma (ALCL).
- Works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or ICON the Contract Research Organization (CRO) that is helping to conduct the study or are directly-related to anyone that works for Establishment Labs, Motiva USA or any of their subsidiaries, the study surgeon, or the CRO.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Primary Breast Reconstruction Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants Subjects age 18 and over, Surgery to replace breast tissue that has been removed due to cancer, prophylactic mastectomy, breast trauma or that has failed to develop properly due to a severe breast anomaly. Primary Breast Augmentation Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants Subjects age 22 and over, indicated to increase breast size Revision Augmentation Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants Revision surgery to correct or improve the results of a previous breast augmentation Revision Reconstruction Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants Revision surgery to correct or improve the results of a previous breast reconstruction.
- Primary Outcome Measures
Name Time Method Analyze and report the total adverse events rate ("any complication)" of the Silicone Gel filled Motiva Implants®. Kaplan-Meier analysis of adverse events will be conducted by time period for each type of adverse event. 10 Years Analyze patient satisfaction on a 5-point Likert scale post-implant for all implantation groups. 10 Years
- Secondary Outcome Measures
Name Time Method Cox regression analyses for the following endpoints: Capsular contracture III/IV, Breast Pain, Infection, and Implant Rupture 10 Years Kaplan-Meier analysis of Cancer (Breast Cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), and others) 10 Years Patient Satisfaction with Breast (BREAST-Q™) Questionnaire 10 Years Physician Satisfaction (5-point Likert scale) 10 Years Breast Measurements (Net Chest Circumference and Hemi-Circumference) change from baseline 10 Years Kaplan-Meier analysis of all complications, including reoperation and explantation 10 Years Kaplan-Meier analysis of connective tissue disease (CTD) and CTD signs/symptoms 10 Years Kaplan-Meier analysis of rupture. 10 Years Validated Quality of Life questionnaires 10 Years
Trial Locations
- Locations (29)
The Center for Cosmetic Surgery
🇺🇸Golden, Colorado, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Northwestern Plastic Surgery
🇺🇸Chicago, Illinois, United States
Northwestern Specialists in Plastic Surgery, S.C.
🇺🇸Chicago, Illinois, United States
Gerald Minitti, MD, FACS
🇺🇸Beverly Hills, California, United States
Steven Teitelbaum, MD, FACS
🇺🇸Santa Monica, California, United States
Fifth Avenue Millennium Aesthetic Surgery, PLLC
🇺🇸New York, New York, United States
Cleveland Clinic Main Campus
🇺🇸Cleveland, Ohio, United States
Movassaghi Plastic Surgery & Ziba Medical Spa
🇺🇸Eugene, Oregon, United States
Portland Plastic Surgery
🇺🇸Portland, Oregon, United States
Body by Z
🇺🇸Providence, Rhode Island, United States
Maxwell Aesthetics, PLLC
🇺🇸Nashville, Tennessee, United States
Strock Plastic Surgery
🇺🇸Fort Worth, Texas, United States
Houston Methodist
🇺🇸Houston, Texas, United States
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States
William P. Adams Plastic Surgery
🇺🇸University Park, Texas, United States
PeaceHealth Plastic Surgery
🇺🇸Vancouver, Washington, United States
Plastische Chirurgie im Medienhafen
🇩🇪Dusseldorf, Germany
Victoriakliniken
🇸🇪Stockholm, Sweden
Westlake Cosmetic Surgery Center
🇺🇸Westlake Village, California, United States
Meridian Plastic Surgery Center
🇺🇸Indianapolis, Indiana, United States
CaloAesthetics® Plastic Surgery Center
🇺🇸Louisville, Kentucky, United States
The Wall Center for Plastic Surgery
🇺🇸Shreveport, Louisiana, United States
Partners in Plastic Surgery of West Michigan
🇺🇸Grand Rapids, Michigan, United States
Parkcrest Plastic Surgery
🇺🇸Saint Louis, Missouri, United States
Glicksman Plastic Surgery
🇺🇸Sea Girt, New Jersey, United States
Mark D. Epstein, MD, FACS/ Center for Aesthetic Surgery
🇺🇸Hauppauge, New York, United States
NYU Plastic Surgery Associates
🇺🇸New York, New York, United States
May Center for Mount Sinai Doctors
🇺🇸New York, New York, United States