NCT06792409

Mia® Clinical Study

Motiva Mia® Pilot Study to Evaluate the Safety and Initial Effectiveness of the Procedure and System Devices, Including Motiva Implants® Ergonomix2 Diamond® in Subjects Undergoing Primary Breast Augmentation Procedures

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Establishment Labs · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This study will follow 100 women over 36 months (3 years) to evaluate how safe and effective a minimally invasive breast augmentation procedure is. The women will have their first breast augmentation surgery using Motiva® Ergonomix2 Diamond® implants, Motiva Injector® and Motiva® Inflatable Balloon.

Detailed description

This is a prospective follow-up, 36-month, open, interventional study to confirm the safety and effectiveness of the procedure and system devices, including Motiva® Ergonomix2 Diamond® implants in women subjected to primary breast augmentation. This study will enroll 100 women who will undergo a minimally invasive breast augmentation procedure with Ergonomix2 Diamond® using Motiva Injector® MIA and the Motiva MIA® inflatable balloon. The study duration will be 36 months and a six-month enrollment window was planned. Recruitment will take place after enrollment and before any clinical research procedures, a participant will sign and date the Informed Consent Form. This will be considered the intent-to-treat (ITT) population. Since there will be a subset of women who will provide their consent to participate but will not undergo the procedure (i.e., due to a screening failure or consent withdrawal before the surgery, the analysis population for this study will be the full analysis set ("treated population") which will be made up by women that have received the implant(s) and that have at least one postop evaluation. A Magnetic Resonance Imaging (MRI) substudy will be performed to determine the rate of silent rupture (no signs or symptoms) both extra- and intracapsular, and to identify displacement and/or gel fracture. MRI scans in this study will be performed on participants who are 18 to 21 months post-op. However, any study participant, whether or not participating in this sub study, who presents with signs or symptoms suggestive of a rupture, will be referred for MRI evaluation at any time during the study. Information obtained from the MRI study will be collected on the MRI Case Report Form by the investigator. The proposed sample size of 33 participants in the MRI substudy, considered to be the industry standard, one third of the total sample participating in the Motiva MIA® study, and who consent to participate in this substudy.

Conditions

• Breast Augmentation

Interventions

Type	Name	Description
DEVICE	Minimally invasive breast augmentation procedure with a trans-axillary approach.	Minimally invasive breast augmentation procedure with a transaxillary approach using Motiva Ergonomix2 Diamond®, Motiva Injector® and Motiva® Inflatable Balloon.

Timeline

• Start date: 2020-12-03
• Primary completion: 2024-08-08
• Completion: 2024-12-30
• First posted: 2025-01-24
• Last updated: 2025-01-24

Locations

1 site across 1 country: Costa Rica