Mia® Clinical Study

NCT ID: NCT06792409

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-03
• Study Completion Date: 2024-12-30

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.

Conditions

Breast Augmentation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Minimally Invasive breast augmentation

Minimally invasive breast augmentation procedure with a trans-axillary approach.

Group Type: EXPERIMENTAL

Minimally invasive breast augmentation procedure with a trans-axillary approach.

Intervention Type: DEVICE

Minimally invasive breast augmentation procedure with a transaxillary approach using Motiva Ergonomix2 Diamond®, Motiva Injector® and Motiva® Inflatable Balloon.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Inflatable Balloon; Injector; Ergonomix breast implants

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

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Establishment Labs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Centro Europeo de Cirugía

San José, , Costa Rica

Countries

Costa Rica

Other Identifiers

CLINP-001007 CR

Identifier Type: -

Identifier Source: org_study_id