Motiva Implants® Post-Approval Study (NCT06938399) | Clinical Trial Compass
RecruitingNot Applicable
Motiva Implants® Post-Approval Study
United States2,400 participantsStarted 2025-05-01
Plain-language 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.
Who can participate
Age range22 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 condi…
What they're measuring
1
Investigate the incidence of connective tissue disease (CTD) signs and symptoms in Motiva implanted participants compared to the incidence in control participants