Actively Recruiting
Safety and Performance of Motiva® Sizers
Led by Establishment Labs · Updated on 2024-02-23
330
Participants Needed
1
Research Sites
221 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Motiva® Sizer clinical study is a four-year, multicenter, post-marketing, and cohort study, designed to confirm the safety and performance of Motiva® Sizer in breast augmentation or reconstruction procedures. The research will include 330 women, divided into two groups of 165 participants each (150 breast augmentation participants and 15 reconstruction participants). The Motiva® Sizer exposed group will consist of women who will undergo breast augmentation or reconstruction surgery with the use of Motiva® Sizer during the procedure, and a non-exposed group will consist of women who will undergo breast augmentation or reconstruction surgery without the use of Motiva® Sizer. This study will be conducted in Costa Rica. The main goal is to evaluate the safety and the performance of the Motiva® Sizer. To this end, the results of both groups will be compared in terms of surgical complications, surgeon's, and participant's satisfaction level as well as reoperation rates. After the augmentation or reconstruction surgery, participants will be scheduled for the following follow-up visits, (1) between 3 and 7 postoperative days, (2) between 3 and 6 postoperative weeks, (3) at 3 and (4) 6 postoperative months, and (5, 6 and 7) annually thereafter for a period of three consecutive years. In case any participant has an adverse event due to the procedure, and if required by the physician, an additional visit will be made to assess her, and this information as well as that of the scheduled visits should be recorded in the electronic data collection notebook.
CONDITIONS
Official Title
Safety and Performance of Motiva® Sizers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, 18 years of age or older.
- Undergoing breast augmentation or reconstruction surgery.
- Have enough healthy tissue to cover the breast implants.
- Willing to follow all study requirements, including signing consent and attending all follow-up visits.
You will not qualify if you...
- Existing rib injuries.
- Having inadequate or unsuitable tissue for breast surgery.
- History of abscesses or infections in the breast area.
- Currently pregnant or breastfeeding, or within 6 months postpartum.
- History of sensitivity to silicone.
- Medical conditions that increase surgical risk or postoperative complications, including underweight or obesity, diabetes, autoimmune diseases, severe lung or heart disease, or psychological disorders.
- Active or recurrent breast cancer.
- Using medications that increase risk of complications or affect healing, such as corticosteroids or blood clotting drugs like warfarin.
- Not residing in the country where the surgery is performed, preventing attendance of follow-up visits.
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Trial Site Locations
Total: 1 location
1
Establishment Labs
Coyol, Alajuela Province, Costa Rica, 20102
Actively Recruiting
Research Team
G
Gamboa
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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