Clinical trial NCT03579901: Study of the Safety and Effectiveness of Motiva Implants®
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Implants
Keywords: Breast Implants
Breast Surgery
Breast Augmentation
Breast Reconstruction
Lead sponsor: Motiva USA LLC
Sponsor class: INDUSTRY
First posted: 2018-07-09
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter Single arm
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 10 Years
measure: Analyze patient satisfaction on a 5-point Likert scale post-implant for all implantation groups.
timeFrame: 10 Years
Secondary outcomes:
measure: Kaplan-Meier analysis of all complications, including reoperation and explantation
timeFrame: 10 Years
measure: Cox regression analyses for the following endpoints: Capsular contracture III/IV, Breast Pain, Infection, and Implant Rupture
timeFrame: 10 Years
measure: Kaplan-Meier analysis of rupture.
timeFrame: 10 Years
measure: Kaplan-Meier analysis of connective tissue disease (CTD) and CTD signs/symptoms
timeFrame: 10 Years
measure: Kaplan-Meier analysis of Cancer (Breast Cancer, Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL), and others)
timeFrame: 10 Years
measure: Patient Satisfaction with Breast (BREAST-Q™) Questionnaire
timeFrame: 10 Years
measure: Physician Satisfaction (5-point Likert scale)
timeFrame: 10 Years
measure: Validated Quality of Life questionnaires
timeFrame: 10 Years
measure: Breast Measurements (Net Chest Circumference and Hemi-Circumference) change from baseline
timeFrame: 10 Years
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Gerald Minitti, MD, FACS
state: California
city: Santa Monica
country: United States
facility: Steven Teitelbaum, MD, FACS
state: California
city: Westlake Village
country: United States
facility: Westlake Cosmetic Surgery Center
state: California
city: Golden
country: United States
facility: The Center for Cosmetic Surgery
state: Colorado
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Plastic Surgery
state: Illinois
city: Chicago
country: United States
facility: Northwestern Specialists in Plastic Surgery, S.C.
state: Illinois
city: Indianapolis
country: United States
facility: Meridian Plastic Surgery Center
state: Indiana
city: Louisville
country: United States
facility: CaloAesthetics® Plastic Surgery Center
state: Kentucky
city: Shreveport
country: United States
facility: The Wall Center for Plastic Surgery
state: Louisiana
city: Grand Rapids
country: United States
facility: Partners in Plastic Surgery of West Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Parkcrest Plastic Surgery
state: Missouri
city: Sea Girt
country: United States
facility: Glicksman Plastic Surgery
state: New Jersey
city: Hauppauge
country: United States
facility: Mark D. Epstein, MD, FACS/ Center for Aesthetic Surgery
state: New York
city: New York
country: United States
facility: NYU Plastic Surgery Associates
state: New York
city: New York
country: United States
facility: May Center for Mount Sinai Doctors
state: New York
city: New York
country: United States
facility: Fifth Avenue Millennium Aesthetic Surgery, PLLC
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Main Campus
state: Ohio
city: Eugene
country: United States
facility: Movassaghi Plastic Surgery & Ziba Medical Spa
state: Oregon
city: Portland
country: United States
facility: Portland Plastic Surgery
state: Oregon
city: Providence
country: United States
facility: Body by Z
state: Rhode Island
city: Nashville
country: United States
facility: Maxwell Aesthetics, PLLC
state: Tennessee
city: Fort Worth
country: United States
facility: Strock Plastic Surgery
state: Texas
city: Houston
country: United States
facility: Houston Methodist
state: Texas
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: University Park
country: United States
facility: William P. Adams Plastic Surgery
state: Texas
city: Vancouver
country: United States
facility: PeaceHealth Plastic Surgery
state: Washington
city: Dusseldorf
country: Germany
facility: Plastische Chirurgie im Medienhafen
city: Stockholm
country: Sweden
facility: Victoriakliniken
Study officials:
References: