Mia® Clinical Study

NCT06792409 | Completed

• 1 other identifier: CLINP-001007 CR
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Augmentation

Keywords

Mia; Breast; augmentation; Minimally invasive; Transaxillar; Transaxillary; Motiva; Injector; Balloon; Inflatable Balloon; Ergonomix2; Implants; Dissector; Implant; Silicone; Diamond

Outcome Measures

Primary Outcomes (2)

• Safety

  Cumulative incidence (number of cases) of adverse events during surgery and the follow-up period, severity and duration of all complications (rate of adverse events related to the procedure / adverse events related to the device).

  From minimally invasive procedure through study completion, an average of 3 years.

• Effectiveness

  Effectiveness will be measured as satisfactory on all breast augmentation procedures using Mia® devices if no device failures have occurred.

  From minimally invasive procedure through study completion, an average of 3 years.

Secondary Outcomes (4)

• Patient satisfaction

  From week 1 post-procedure to the end of the follow-up period

• Patient satisfaction

  From week 1 post-procedure to the end of the follow-up period

• Patient satisfaction

  From week 1 post-procedure to the end of the follow-up period

• Surgeon satisfaction

  During minimally invasive procedure

Other Outcomes (3)

• Device Malfuctioning

  During minimally invasive procedure

• Use of conventional surgical techniques

  During minimally invasive procedure

• Surgical pocket

  During minimally invasive procedure

Study Arms (1)

Minimally Invasive breast augmentation

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: Inflatable Balloon, Injector, Ergonomix breast implants

Minimally Invasive breast augmentation

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Genetic females, ≥ 18 years.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Establishment Labs: lead

Study Sites (1)

Centro Europeo de Cirugía

San José, Costa Rica

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: January 24, 2025
• Study Start: December 3, 2020
• Primary Completion: August 8, 2024
• Study Completion: December 30, 2024
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

CO (1)