Safety and Performance of Motiva® Sizers

Establishment Labs

Status: Enrolling

Conditions: Breast Reconstruction; Breast Implantation; Methods, Safety and Performance; Breast Augmentation; Breast Implant; Complications; Mammaplasty

Treatments: Device: Motiva Sizer

Study type: Observational

Funder types: Industry

Identifiers

NCT06274736

CLINP-001012

Details and patient eligibility

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.

Enrollment: 330 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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 .

Trial design

330 participants in 2 patient groups

Women who will undergo a breast augmentation or reconstruction with Motiva® Sizer during surgery.

Treatment:

Device: Motiva Sizer

Women who will undergo a breast augmentation or reconstruction without Motiva® Sizer during surgery.