Safety and Performance of Motiva® Sizers

NCT ID: NCT06274736

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 330 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-10
• Study Completion Date: 2027-07-10

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Motiva Sizer

Intervention Type: DEVICE

No intervention will be made,

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

No interventions assigned to this group

Interventions

Motiva Sizer

No intervention will be made,

Intervention Type: DEVICE

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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Establishment Labs

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Establishment Labs

Coyol, Alajuela Province, Costa Rica

Site Status: RECRUITING

Countries

Costa Rica

Central Contacts

Gamboa

Role: CONTACT

sgamboa@establishmentlabs.com

+506 2434 2400

Other Identifiers

CLINP-001012

Identifier Type: -

Identifier Source: org_study_id