Clinical trial NCT06792409: Mia® Clinical Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Augmentation
Keywords: Mia
Breast
augmentation
Minimally invasive
Transaxillar
Transaxillary
Motiva
Injector
Balloon
Inflatable Balloon
Ergonomix2
Implants
Dissector
Implant
Silicone
Diamond
Lead sponsor: Establishment Labs
Sponsor class: INDUSTRY
First posted: 2025-01-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Genetic females, ≥ 18 years.
* AA to C cup size, evaluated according to Triumph international guidelines.
* Participants with Class I and II risk according to the American Society of Anesthesiologists (ASA)
* Participants seeking a primary breast augmentation to increase the size of their breasts by one cup size.
* Body Mass Index between 18.5 and 24.9 (normal weight).
* Adequate tissue for covering the implant(s).
* Willingness to follow all study requirements and attending all necessary follow-up visits.
* Agreement to return the device to the sponsor in case it is explanted

Exclusion Criteria:

* Current costal lesions.
* Breast ptosis or poor skin quality.
* Inadequate tissue (for example, radiation damage, ulcers, compromised vascularity, history of inadequate wound scaring).
* History of abscesses or infections in the breast area.
* Currently pregnant or breastfeeding, or pregnancy or breastfeeding to term in the six months prior to recruitment.
* History of silicone sensitivity.
* Use of any medications that interfere with coagulation or that may imply a high risk and/or significant post-surgical complication.
* Any medical condition, such as low weight or obesity according to the inclusion criteria, diabetes, autoimmune disease, chronic lung disease or serious cardiovascular disease that may result in an excessively high surgical risk and/or important post-surgical complications.
* Any condition that precludes the use of magnetic resonance imaging (MRI), including implanted metal devices, claustrophobia or other conditions that preclude MRI exploration.
* Any history of psychological characteristics that are not realistic or reasonable, considering the risks involved with the surgical procedure.
* Use of any medications that, according to the investigator, may imply a higher risk of complications or interference with wound healing ability, such as corticosteroids or anticoagulants (i.e., concomitant warfarin therapy).
* Current participation on studies for investigation devices or pharmaceutical products.
* Participants not residing in Costa Rica, which precludes their attendance to follow-up visits.
* Sponsor (or any of its subsidiaries) employees, study investigator or any person helping to conduct the study; direct (family) relationship with any sponsor (or any of its subsidiaries) or investigator employees.

Primary outcomes:
measure: Safety
timeFrame: From minimally invasive procedure through study completion, an average of 3 years.
measure: Effectiveness
timeFrame: From minimally invasive procedure through study completion, an average of 3 years.
Secondary outcomes:
measure: Patient satisfaction
timeFrame: From week 1 post-procedure to the end of the follow-up period
measure: Patient satisfaction
timeFrame: From week 1 post-procedure to the end of the follow-up period
measure: Patient satisfaction
timeFrame: From week 1 post-procedure to the end of the follow-up period
measure: Surgeon satisfaction
timeFrame: During minimally invasive procedure
Other outcomes:
measure: Device Malfuctioning
timeFrame: During minimally invasive procedure
measure: Use of conventional surgical techniques
timeFrame: During minimally invasive procedure
measure: Surgical pocket
timeFrame: During minimally invasive procedure
Locations:
city: San José
country: Costa Rica
facility: Centro Europeo de Cirugía
Study officials:
References: