Study of the Safety and Effectiveness of Motiva Implants®
NCT ID: NCT03579901
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
800 participants
INTERVENTIONAL
2018-04-06
2033-02-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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Primary Breast Augmentation
Subjects age 22 and over, indicated to increase breast size
Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
Breast augmentation
Primary Breast Reconstruction
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.
Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
Breast augmentation
Revision Augmentation
Revision surgery to correct or improve the results of a previous breast augmentation
Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
Breast augmentation
Revision Reconstruction
Revision surgery to correct or improve the results of a previous breast reconstruction.
Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
Breast augmentation
Interventions
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Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
Breast augmentation
Eligibility Criteria
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Inclusion Criteria
* Patient is seeking one of the following procedures:
Primary Breast Augmentation Primary Breast Reconstruction Revision Augmentation Revision Reconstruction
* Patient has adequate tissue available to cover implant(s).
* Willingness to follow all study requirements including agreeing to attend all required follow-up visits and signs the informed consent.
* Agrees to have device returned to Establishment Labs if explanted.
* Willing to undergo Magnetic Resonance Imaging (MRI) evaluation of medically advised.
Exclusion Criteria
* 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.
18 Years
70 Years
FEMALE
Yes
Sponsors
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Motiva USA LLC
INDUSTRY
Responsible Party
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Locations
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Gerald Minitti, MD, FACS
Beverly Hills, California, United States
Steven Teitelbaum, MD, FACS
Santa Monica, California, United States
Westlake Cosmetic Surgery Center
Westlake Village, California, United States
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
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
St 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
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
Düsseldorf, , Germany
Victoriakliniken
Stockholm, , Sweden
Countries
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Other Identifiers
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CLIN-17-008
Identifier Type: -
Identifier Source: org_study_id