Last updated on August 2018

Study of the Safety and Effectiveness of Motiva Implants

Brief description of study

This study evaluates the safety and effectiveness Motiva Implants in women who are undergoing primary breast augmentation, primary breast reconstruction or revision breast surgery.

Detailed Study Description

Motiva Implants Silicone Gel-filled Breast Implants, SmoothSilk both Round and Ergonomix, have not been approved by FDA, and the purpose of this study is to collect scientific evidence of the safety and effectiveness of these implants. Motiva Implants have been approved for commercial distribution in over 60 countries, including the United Kingdom, Sweden, Germany, Switzerland, Austria, Japan, Australia, Brazil, and South Korea.

This clinical study is a multicenter, single arm study. The population consist of 750 patients in four cohorts and an MRI subpopulation of 250 patients to verify the rates of rupture.

Safety will be assess by incidence, severity, method of resolution, and duration for all complications on a per implant and per subject basis. And effectiveness will be measured by and overall patient satisfaction, and co-primary endpoints for breast measurements. As secondary endpoints physician satisfaction and three quality of life questionnaires annually and at 1,2,4,6,8 and 10 years respectively.

Patients will be follow up through a 10 year period to guaranty the safeness of the devices, patients will attend a baseline visit and from the day of subjects will be asked to make visits at the following time periods after the surgery: 3-6 weeks, 1, 2, 3, 4, 5, 6, 7, 8, 9 and 10 years. Each investigator will perform an evaluation of the status of the implant and will examined the presence of any post-surgical complications.

Specifically, for primary augmentation subjects, breast measurements and 3D imaging and for all subjects' photographs, an evaluation of your nipple and breast sensitivity will be performed.

It is the investigators choice if additional 3D imaging will be performed for subjects in the revision augmentation, primary reconstruction and revision reconstruction cohorts at any or all of the annual study visits.

A review of the subjects current medications, continued cancer therapy (if applicable), mammography results (if applicable), and MRI scan at visits 1, 2, 4, 6, 8, and 10 (for MRI sub-study subjects) could also be conducted. In addition, study investigators will evaluate the breasts for capsular contracture and any other complications that may arise, annually and in unscheduled visits.

Clinical Study Identifier: NCT03579901

Contact Investigators or Research Sites near you

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Rebeca Madrigal

Glicksman Plastic Surgery
Sea Girt, NJ United States
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Recruitment Status: Open

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