Study of the Safety and Effectiveness of Motiva Implants®

Breast Implants Clinical Trial

Official title:

Study of the Safety and Effectiveness of the Motiva Implants® Silicone Gel-Filled Breast Implants SmoothSilk® in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03579901
• Other study ID #: CLIN-17-008
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 6, 2018
• Est. completion date: February 28, 2033

Study information

• Verified date: March 2023
• Source: Motiva USA LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: February 28, 2033
• Est. primary completion date: August 30, 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria

• Genetic female.
• 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 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.

Related Conditions & MeSH terms

• Breast Implants

Intervention

Device:
• Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
Breast augmentation

Locations

Country	Name	City	State
Germany	Plastische Chirurgie im Medienhafen	Dusseldorf
Sweden	Akademikliniken HJ AB	Stockholm
Sweden	Victoriakliniken	Stockholm
United States	Emory University Hospital	Atlanta	Georgia
United States	Brian M. Kinney, MD, FACS-Excellence in Plastic Surgery	Beverly Hills	California
United States	Gerald Minitti, MD, FACS	Beverly Hills	California
United States	Northwestern Plastic Surgery	Chicago	Illinois
United States	Northwestern Specialists in Plastic Surgery, S.C.	Chicago	Illinois
United States	Cleveland Clinic Main Campus	Cleveland	Ohio
United States	Movassaghi Plastic Surgery & Ziba Medical Spa	Eugene	Oregon
United States	Strock Plastic Surgery	Fort Worth	Texas
United States	The Center for Cosmetic Surgery	Golden	Colorado
United States	Partners in Plastic Surgery of West Michigan	Grand Rapids	Michigan
United States	Mark D. Epstein, MD, FACS/ Center for Aesthetic Surgery	Hauppauge	New York
United States	Houston Methodist	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Meridian Plastic Surgery Center	Indianapolis	Indiana
United States	CaloAesthetics® Plastic Surgery Center	Louisville	Kentucky
United States	Maxwell Aesthetics, PLLC	Nashville	Tennessee
United States	Fifth Avenue Millennium Aesthetic Surgery, PLLC	New York	New York
United States	May Center for Mount Sinai Doctors	New York	New York
United States	NYU Plastic Surgery Associates	New York	New York
United States	Portland Plastic Surgery	Portland	Oregon
United States	Body by Z	Providence	Rhode Island
United States	Parkcrest Plastic Surgery	Saint Louis	Missouri
United States	Steven Teitelbaum, MD, FACS	Santa Monica	California
United States	Glicksman Plastic Surgery	Sea Girt	New Jersey
United States	The Wall Center for Plastic Surgery	Shreveport	Louisiana
United States	Rafael Gottenger, MD Plastic Surgery	South Miami	Florida
United States	William P. Adams Plastic Surgery	University Park	Texas
United States	PeaceHealth Plastic Surgery	Vancouver	Washington
United States	Westlake Cosmetic Surgery Center	Westlake Village	California

Sponsors (1)

Lead Sponsor	Collaborator
Motiva USA LLC

Countries where clinical trial is conducted

United States,  Germany,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Analyze patient satisfaction on a 5-point Likert scale post-implant for all implantation groups.		10 Years
Secondary	Kaplan-Meier analysis of all complications, including reoperation and explantation		10 Years
Secondary	Cox regression analyses for the following endpoints: Capsular contracture III/IV, Breast Pain, Infection, and Implant Rupture		10 Years
Secondary	Kaplan-Meier analysis of rupture.		10 Years
Secondary	Kaplan-Meier analysis of connective tissue disease (CTD) and CTD signs/symptoms		10 Years
Secondary	Kaplan-Meier analysis of Cancer (Breast Cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), and others)		10 Years
Secondary	Patient Satisfaction with Breast (BREAST-Q™) Questionnaire		10 Years
Secondary	Physician Satisfaction (5-point Likert scale)		10 Years
Secondary	Validated Quality of Life questionnaires		10 Years
Secondary	Breast Measurements (Net Chest Circumference and Hemi-Circumference) change from baseline		10 Years