Status:
RECRUITING
Motiva Implants® Post-Approval Study
Lead Sponsor:
Motiva USA LLC
Conditions:
Breast Implant
Eligibility:
FEMALE
22+ years
Phase:
NA
Brief 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.
Detailed Description
Prospective, non-randomized, multicenter study including baseline (preoperative), operative, and postoperative data collection annually Years 1-10.
Eligibility Criteria
Inclusion
- Inclusion Criteria Motiva Implants®:
- 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
- Inclusion Criteria Control group:
- 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 Criteria Motiva Implants®:
- 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)
- Exclusion Criteria Control group:
- 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
Exclusion
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2037
Estimated Enrollment :
2400 Patients enrolled
Trial Details
Trial ID
NCT06938399
Start Date
May 1 2025
End Date
July 31 2037
Last Update
December 30 2025
Active Locations (23)
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1
J. Gerald Minniti, M.D., F.A.C.S.
Beverly Hills, California, United States, 90212
2
AESTHETX Center
Camp Pendleton, California, United States, 95008
3
Align Surgical Associates Inc
San Francisco, California, United States, 94115
4
Schwartz Aesthetic Institute
Westlake Village, California, United States, 91361