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Safety and Performance of Motiva® Sizers

Breast Reconstruction Clinical Trial

Official title:
Post-marketing Cohort Study to Confirm the Safety and Performance of Motiva® Sizers in Breast Augmentation and Reconstruction Procedures

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06274736
Study type Observational
Source Establishment Labs
Contact Gamboa
Phone +506 2434 2400
Email sgamboa@establishmentlabs.com
Status Recruiting
Phase
Start date April 10, 2023
Completion date July 10, 2027
View Details
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