Evaluating the safety and performance of Motiva® Sizers in breast surgery
Post-marketing Cohort Study to Confirm the Safety and Performance of Motiva® Sizers in Breast Augmentation and Reconstruction Procedures
Establishment Labs · NCT06274736
This study is testing whether using Motiva® Sizers during breast surgery helps improve safety and satisfaction for women compared to those who don’t use them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 330 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Establishment Labs (industry) |
| Locations | 1 site (Coyol, Alajuela Province) |
| Trial ID | NCT06274736 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the safety and performance of Motiva® Sizers in breast augmentation and reconstruction procedures over a four-year period. It will involve 330 women, divided into two groups: one receiving the Motiva® Sizer during surgery and a control group undergoing the procedure without it. The study will compare surgical complications, satisfaction levels of both surgeons and participants, and reoperation rates between the two groups. Conducted in Costa Rica, this multicenter study seeks to provide valuable insights into the effectiveness of this innovative device.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who are undergoing breast augmentation or reconstruction and have adequate tissue for the procedure.
Not a fit: Patients with existing rib injuries, inadequate tissue for surgery, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance surgical outcomes and patient satisfaction in breast augmentation and reconstruction procedures.
How similar studies have performed: While this study focuses on a specific device, similar studies evaluating breast implant safety and performance have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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 .
Where this trial is running
Coyol, Alajuela Province
- Establishment Labs — Coyol, Alajuela Province, Costa Rica (RECRUITING)
Study contacts
- Study coordinator: Gamboa
- Email: sgamboa@establishmentlabs.com
- Phone: +506 2434 2400
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Implant, Complications, Breast Implantation, Methods, Safety and Performance, Mammaplasty, Breast Reconstruction, Breast Augmentation