| NCT ID | NCT06938399 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Motiva USA LLC |
| Condition | Breast Implant |
| Study Type | INTERVENTIONAL |
| Enrollment | 2,400 participants |
| Start Date | 2025-05-01 |
| Primary Completion | 2037-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 2,400 participants in total. It began in 2025-05-01 with a primary completion date of 2037-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06938399 clinical trial?
This trial is open to female participants only, aged 22 Years or older, studying Breast Implant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06938399 currently recruiting?
Yes, NCT06938399 is actively recruiting participants. Contact the research team at CIP-001005+enrollment@establishmentlabs.com for enrollment information.
Where is the NCT06938399 trial being conducted?
This trial is being conducted at Beverly Hills, United States, Beverly Hills, United States, Camp Pendleton, United States, Los Gatos, United States and 11 additional locations.
Who is sponsoring the NCT06938399 clinical trial?
NCT06938399 is sponsored by Motiva USA LLC. The trial plans to enroll 2,400 participants.