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Mia® Clinical Study

NCT06792409 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-24

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Establishment Labs

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-12-03
Primary Completion
2024-08-08
Completion
2024-12-30

Countries

  • Costa Rica

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06792409 on ClinicalTrials.gov