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Clinical Trials in the USA / NCT06938399
Recruiting Not applicable

Motiva Implants® Post-Approval Study

NCT06938399 · tracked via the Priya Life Science USA tracker
Sponsor
Motiva USA LLC
Phase
Not applicable
Started
2025-05-01
Last updated
2026-07-17

Condition(s) studied

Breast Implant

Investigational drug(s) / intervention(s)

Silicone gel-filled breast implants - Motiva Implants®Aesthetic Surgery

Silicone gel-filled breast implants - Motiva Implants®: Breast Surgery

Aesthetic Surgery: Aesthetic procedure other than breast implant surgery

Study 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
FEMALE
Min age
22 Years
Max age
Healthy volunteers
Accepted
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

Primary outcome measure(s)

Trial sites (33)

FacilityCityRegionStatus
The Practice Healthcare Beverly Hills California Recruiting
J. Gerald Minniti, M.D., F.A.C.S. Beverly Hills California Recruiting
AESTHETX Center Camp Pendleton California Recruiting
Los Gatos Plastic Surgery Los Gatos California Recruiting
Align Surgical Associates Inc San Francisco California Recruiting
Schwartz Aesthetic Institute Westlake Village California Recruiting
The Center for Cosmetic Surgery Denver Colorado Recruiting
Advanced Plastic Surgery, LLC Washington D.C. District of Columbia Recruiting
Careaga Plastic Surgery Coral Gables Florida Recruiting
Alicia Billington Plastic Surgery LLC St. Petersburg Florida Recruiting
Iteld Plastic Surgery Chicago Illinois Recruiting
Renee Burke Plastic Surgery, Aesthetics, & Med Spa South Barrington Illinois Recruiting
CaloAesthetics® Plastic Surgery Center Louisville Kentucky Recruiting
The Wall Center for Plastic Surgery Shreveport Louisiana Recruiting
Belcara Health Baltimore Maryland Recruiting
Center for Plastic Surgery Chevy Chase Maryland Recruiting
Parkcrest Plastic Surgery St Louis Missouri Recruiting
Delaware Valley Plastic Surgery Cherry Hill New Jersey Recruiting
Caroline A. Glicksman MD Sea Girt New Jersey Recruiting
Mark D. Epstein, MD, FACS Center for Aesthetic Surgery Hauppauge New York Recruiting
Neinstein Plastic Surgery New York New York Recruiting
HKB Cosmetic Surgery Charlotte North Carolina Recruiting
Capizzi, MD Cosmetic Surgery & Med Spa Charlotte North Carolina Recruiting
Jones Plastic Surgery Oklahoma City Oklahoma Recruiting
Landis Platic Surgery Tulsa Oklahoma Recruiting
Restora Austin Plastic Surgery Center Austin Texas Recruiting
Austin Plastic Surgeon Austin Texas Recruiting
Dallas Day Surgery of Texas North Dallas Texas Recruiting
Southwest Plastic Surgery El Paso Texas Recruiting
Aesthetic Center for Plastic Surgery Houston Texas Recruiting
Kristy Hamilton MD, FACS Houston Texas Recruiting
North Texas Plastic Surgery Southlake Texas Recruiting
The Plastics Clinic & SPA South Jordan Utah Recruiting

More Motiva USA LLC trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06938399 on ClinicalTrials.gov ↗ ← All trials in the USA