Clinical trial NCT06274736: Safety and Performance of Motiva® Sizers
Official title: Post-marketing Cohort Study to Confirm the Safety and Performance of Motiva® Sizers in Breast Augmentation and Reconstruction Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Implant; Complications
Breast Implantation; Methods, Safety and Performance
Mammaplasty
Breast Reconstruction
Breast Augmentation
Lead sponsor: Establishment Labs
Sponsor class: INDUSTRY
First posted: 2024-02-23
Enrollment: 330
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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: 165 participants (150 breast augmentation participants and 15 reconstruction participants).
* Group not exposed to Motiva® Sizer: 165 participants (150 breast augmentation participants and 15 reconstruction participants).

Brief 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.


Eligibility 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 .

Primary outcomes:
measure: Motiva Sizers Safety (complications)
timeFrame: 3 years
measure: Motiva Sizers Performance (satisfaction)
timeFrame: 3 years
Secondary outcomes:
measure: Motiva Sizers Safety (reoperations)
timeFrame: 3 years
Other outcomes:
Locations:
city: Coyol
country: Costa Rica
facility: Establishment Labs
state: Alajuela
Study officials:
References: