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New treatment option for Breast Implant
Official title Motiva Implants® Post-Approval Study
ClinicalTrials.gov ID: NCT06938399
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Patient has adequate tissue available to cover implant(s)
- Willingness to follow all study requirements
You likely can't join if
- 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
See the full eligibility 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)...
- 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 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
- 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...
- 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...
- Has any connective tissue/autoimmune disorder or rheumatoid disease, such as systemic lupus erythematosus, discoid lupus, scleroderma, or rheumatoid arthritis, among others
The study team makes the final eligibility decision.
Where it's taking place
- Beverly Hills, California, United States
- Camp Pendleton, California, United States
- Los Gatos, California, United States
- San Francisco, California, United States
- Westlake Village, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Coral Gables, Florida, United States
- St. Petersburg, Florida, United States
- Chicago, Illinois, United States
- South Barrington, Illinois, United States
- Louisville, Kentucky, United States
- Shreveport, Louisiana, United States
- Baltimore, Maryland, United States
- Chevy Chase, Maryland, United States
- St Louis, Missouri, United States
- Cherry Hill, New Jersey, United States
- Sea Girt, New Jersey, United States
- Hauppauge, New York, United States
- New York, New York, United States
+ 9 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 22 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beverly Hills, California, United States; Camp Pendleton, California, United States; Los Gatos, California, United States; San Francisco, California, United States; Westlake Village, California, United States; Denver, Colorado, United States and 23 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.