RecruitingNot ApplicableNCT06938399
Motiva Implants® Post-Approval Study
Motiva Implants® Post-Approval Study (PAS) Protocol for Motiva SmoothSilk® Round Ergonomix® ('Ergonomix®') and SmoothSilk® Round ('Round') Breast Implants in Subjects Who Are Undergoing Primary Breast Augmentation, Revision Augmentation and Other Aesthetic Procedures
Sponsor
Motiva USA LLC
Enrollment
2,400 participants
Start Date
May 1, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.
Eligibility
Sex: FEMALEMin Age: 22 Years
Inclusion Criteria12
- Female
- Patient is seeking one of the following procedures: -Primary Breast Augmentation: age 22 and over, indicated to increase breast size -Revision Breast Augmentation: removal and replacement of breast implants (revision) to correct or improve the results of a previous breast augmentation
- Patient has adequate tissue available to cover implant(s)
- Willingness to follow all study requirements
- Signs an Informed Consent
- Agrees to have device returned to the Sponsor, if explanted
- Willing to undergo Computed Tomography Scan (CT), ultrasound, or MRI evaluation, if medically advised
- Is 22 years of age or older
- Female
- Is a candidate for aesthetic surgery (such as liposuction, rhinoplasty, face-lift)
- Signs an Informed Consent
- Willingness to follow all study requirements
Exclusion Criteria19
- Has any breast disease considered to be pre-malignant in one or both breasts or is reporting mutations in BRCA1 or BRCA2
- Has inadequate or unsuitable tissue (e.g., due to radiation damage, ulceration, compromised vascularity, history of compromised wound healing)
- Has an active infection anywhere in their body
- 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 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 Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL)
- Has a history of silicone implants (anywhere in the body)
- Plans to undergo silicone breast implant surgery during the course of the study
- Has an active infection anywhere in their body
- Has a history of cancer (except skin cancer)
- 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
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Interventions
DEVICESilicone gel-filled breast implants - Motiva Implants®
Breast Surgery
OTHERAesthetic Surgery
Aesthetic procedure other than breast implant surgery
Locations(29)
View Full Details on ClinicalTrials.gov
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NCT06938399