Motiva Implants® Post-Approval Study
ConditionBreast Implant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age22+
SponsorMotiva USA LLC
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Silicone gel-filled breast implants - Motiva Implants®
- Aesthetic Surgery
Treatment groups
2,400 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov