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Study of the Safety and Effectiveness of Motiva Implants®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03579901
Recruitment Status : Recruiting
First Posted : July 9, 2018
Last Update Posted : June 20, 2019
Sponsor:
Collaborators:
ICON plc
Experien Group
Biostatistical Consulting, Inc.
Information provided by (Responsible Party):
Motiva USA LLC

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE July 9, 2018
Last Update Posted Date June 20, 2019
Actual Study Start Date  ICMJE April 6, 2018
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2018)
Analyze and report the number of adverse events related to the use of the Silicone Gel filled Motiva Implants®. [ Time Frame: 10 Years ]
Number of Participants with breast implants related adverse events as assessed by the incidence, severity, method of resolution and duration.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT03579901 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Safety and Effectiveness of Motiva Implants®
Official Title  ICMJE Study of the Safety and Effectiveness of the Motiva Implants® Silicone Gel-Filled Breast Implants SmoothSilk®/SilkSurface® in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery
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

Motiva Implants® Silicone Gel-filled Breast Implants, SmoothSilk® both Round and Ergonomix®, have not been approved by FDA, and the purpose of this study is to collect scientific evidence of the safety and effectiveness of these implants. Motiva Implants® have been approved for commercial distribution in over 60 countries, including the United Kingdom, Sweden, Germany, Switzerland, Austria, Japan, Australia, Brazil, and South Korea.

This clinical study is a multicenter, single arm study. The population consist of 800 patients in four cohorts and an MRI subpopulation of 250 patients to verify the rates of rupture.

Safety will be assess by incidence, severity, method of resolution, and duration for all complications on a per implant and per subject basis. And effectiveness will be measured by and overall patient satisfaction, and co-primary endpoints for breast measurements. As secondary endpoints physician satisfaction and three quality of life questionnaires annually and at 1,2,4,6,8 and 10 years respectively.

Patients will be follow up through a 10 year period to guaranty the safeness of the devices, patients will attend a baseline visit and from the day of subjects will be asked to make visits at the following time periods after the surgery: 3-6 weeks, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years. Each investigator will perform an evaluation of the status of the implant and will examined the presence of any post-surgical complications.

Specifically, for primary augmentation subjects, breast measurements and 3D imaging and for all subjects' photographs, an evaluation of your nipple and breast sensitivity will be performed.

It is the investigator´s choice if additional 3D imaging will be performed for subjects in the revision augmentation, primary reconstruction and revision reconstruction cohorts at any or all of the annual study visits.

A review of the subjects current medications, continued cancer therapy (if applicable), mammography results (if applicable), and MRI scan at visits 1, 2, 4, 6, 8, and 10 (for MRI sub-study subjects) could also be conducted. In addition, study investigators will evaluate the breasts for capsular contracture and any other complications that may arise, annually and in unscheduled visits.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Multicenter Single arm
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Breast Implants
Intervention  ICMJE Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
Breast augmentation
Study Arms  ICMJE
  • Primary Breast Augmentation
    Subjects age 22 and over, indicated to increase breast size
    Intervention: Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
  • Primary Breast Reconstruction
    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.
    Intervention: Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
  • Revision Augmentation
    Revision surgery to correct or improve the results of a previous breast augmentation
    Intervention: Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
  • Revision Reconstruction
    Revision surgery to correct or improve the results of a previous breast reconstruction.
    Intervention: Device: Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 23, 2019)
800
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE March 30, 2028
Estimated Primary Completion Date March 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Female
Ages  ICMJE 22 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Rebeca Madrigal 888-8462-915 customerservice@motiva.com
Contact: Ana Vega, MD 888-8462-915 ustrial@establishmentlabs.com
Listed Location Countries  ICMJE Germany,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03579901
Other Study ID Numbers  ICMJE CLIN-17-008
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Motiva USA LLC
Study Sponsor  ICMJE Motiva USA LLC
Collaborators  ICMJE
  • ICON plc
  • Experien Group
  • Biostatistical Consulting, Inc.
Investigators  ICMJE Not Provided
PRS Account Motiva USA LLC
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP