Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New breast surgery methods aim to preserve tissue and speed recovery

NCT ID NCT07623564

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study is testing several new, minimally invasive surgical techniques for breast augmentation and reconstruction. The goal is to preserve natural breast tissue, reduce recovery time, and improve how the breasts look and feel. About 60 women aged 18 and older with cup sizes AA to C are taking part. The study tracks safety issues like infection or tissue damage, and measures satisfaction from both patients and surgeons.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Minimally invasive surgical procedures (Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, Maxtopexia + Mia)
What this could lead to
If successful, these techniques could offer women safer, faster-recovering breast augmentation and reconstruction with more natural results.
What could go wrong
This is a small, early-stage follow-up study with only 60 participants, so results may not apply to everyone. Risks include infection, tissue damage, or unsatisfactory cosmetic outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The study population comprises approximately 60 cisgender women aged 18 years or older who will undergo minimally invasive breast augmentation or benign reconstruction procedures at the Sulàyöm Innovation Campus in Costa Rica. Eligible participants will include women with breast cup sizes ranging from AA to C, classified as ASA I or II, and with sufficient breast tissue to support implant placement. The cohort will include individuals undergoing the following procedures: * Mia Harmonization * Mia Scarless Lift * Mia Reconstruction * Joy Dot * Maxtopexia + Mia Additionally, participants may have congenital or acquired breast conditions (e.g., amastia, tuberous breasts, asymmetry) and meet the specific inclusion criteria for these advanced minimally invasive techniques. Recruitment will focus on women scheduled for surgery between January and December 2025, with follow-up spanning 36 months. Participants must reside in Costa Rica to ensure adherence to follow-up visits.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Gender and Age: Cisgender women, aged 18 years or older. 2. Surgical Procedure: Participants undergoing primary breast augmentation or benign reconstruction using the following minimally invasive procedures: * Mia Harmonization * Mia Scarless Lift * Mia Reconstruction * Joy Dot * Maxtopexia + Mia 3. Breast Size: Cup sizes AA to C, as determined by guidelines from Triumph International. 4. Health Status: ASA (American Society of Anesthesiologists) classification I or II. 5. Tissue Integrity: Adequate breast tissue available to cover the implant(s). 6. Commitment: Willingness to adhere to all study requirements, including follow-up visits and signing the informed consent form. 7. Special Cases for Reconstruction: Participants with congenital or acquired breast or thoracic conditions, such as amastia, pectus excavatum/carinatum, tuberous breasts, or asymmetry. 8. Mia Scarless Lift Specifics: Participants with mild, moderate, or pseudoptosis based on physician evaluation. 9. Timing: Women scheduled for surgery at the Sulàyöm Innovation Campus between January and December 2025. Exclusion Criteria: 1. Non-Specified Procedures: Women undergoing augmentation or reconstruction with techniques other than those listed (Mia Harmonization, Mia Scarless Lift, Mia Reconstruction, Joy Dot, Maxtopexia + Mia). 2. Non-Study Implants: Use of implants other than Motiva products. 3. Compromised Tissue or Skin: * Existing rib lesions or significant/severe breast ptosis. * Poor tissue quality due to radiation damage, vascular compromise, or prior ulceration. 4. Medical History: * History of breast abscesses or infections. * Sensitivity or allergy to silicone. 5. Current Physiological Conditions: -Pregnancy or breastfeeding, or within six months postpartum or post-lactation. 6. Medications: Use of anticoagulants or medications that impair wound healing (e.g., corticosteroids, Warfarin). 7. Imaging Constraints: Conditions that prevent the use of MRI (e.g., implanted metal devices, claustrophobia). 8. Concurrent Research: Participation in another clinical research study involving drugs or devices. 9. Follow-Up Barriers: Residency outside Costa Rica or inability to attend required follow-up visits. 10. Timing Issues: Participants undergoing surgery outside the designated study period (January to December 2025).

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Amastia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Establishment Labs

    Coyol, Alajuela Province, 20113, Costa Rica

More trials for these conditions

Other studies related to the condition(s) this trial covers.