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Are temporary breast sizers safe? new study investigates

NCT ID NCT06274736

Knowledge-focused Sponsor: Establishment Labs Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether using Motiva Sizers during breast augmentation or reconstruction is safe and works well. It included 133 women in Costa Rica, split into two groups: one where the sizer was used and one where it wasn't. Researchers compared complications, satisfaction, and reoperation rates over one year.

What this could mean

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

Active substance
Motiva Sizer (a temporary device used during surgery to help choose the right implant size)
What this could lead to
If successful, this study could confirm that using Motiva Sizers during breast surgery is safe and helps improve patient and surgeon satisfaction.
What could go wrong
This is a small, completed study in one country, so results may not apply to all patients or settings. It only compares outcomes, not a new treatment.

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

133 people

The number who actually took part.

Started

Apr 2023

Finished

Jan 2026

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

Women over 18 years of age who will undergo breast augmentation or reconstruction. They will be divided into two groups: * Group exposed to Motiva® Sizer: 56 participants (51 breast augmentation participants and 5 reconstruction participants). * Group not exposed to Motiva® Sizer: 78 participants (74 breast augmentation participants and 4 reconstruction participants).

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Female, 18 years of age or older. * The participant will be undergoing a breast augmentation or reconstruction procedure. * To possess enough and adequate tissue to cover the implants. * Willingness to comply with all study requirements, including signing the informed consent document and agreeing to attend all required follow-up visits. Exclusion Criteria: * Existing rib injuries. * Inadequate or unsuitable tissue for augmentation or reconstruction surgery at the physician's discretion. * History of abscesses or infections in the breast area. * Current pregnancy or breastfeeding, or full-term pregnancy or breastfeeding in the six months prior to enrollment. * History of sensitivity to silicone. * Any medical condition, such as underweight or obesity, diabetes, autoimmune disease or severe chronic pulmonary or cardiovascular disease, psychological/psychiatric disorders that may result in unduly high surgical risk and/or significant postoperative complications. * Active or recurrent breast cancer. * Consumption of any medication that, in the investigator's experience, may pose an increased risk of complications or interfere with wound healing ability, such as corticosteroid therapy or blood clotting medication (e.g., concomitant treatment with warfarin). * Not living in the country where the procedure was performed , which prevents him/her from attending follow-up visits .

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As listed by the trial registrant

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

Breast augmentation Breast implant complications Breast implantation; methods, safety and performance Breast reconstruction Mammaplasty

Contacts and locations

Locations

  • Establishment Labs

    Coyol, Alajuela Province, 20102, Costa Rica

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