Trials / Active Not Recruiting
Active Not RecruitingNCT03579901
Study of the Safety and Effectiveness of Motiva Implants®
Study of the Safety and Effectiveness of the Motiva Implants® Silicone Gel-Filled Breast Implants SmoothSilk® in Subjects Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction, and Revision Surgery
- Status
- Active Not Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 800 (estimated)
- Sponsor
- Motiva USA LLC · Industry
- Sex
- Female
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Accepted
Summary
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 description
Prospective, Single Arm, Multicenter Study. Following FDA approval, follow-up data will continue to be collected for all cohorts on adverse events, reoperations, patient satisfaction, physician satisfaction and quality of life for a total of 10 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants | Breast augmentation |
Timeline
- Start date
- 2018-04-06
- Primary completion
- 2032-08-30
- Completion
- 2033-02-28
- First posted
- 2018-07-09
- Last updated
- 2025-11-12
Locations
29 sites across 3 countries: United States, Germany, Sweden
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03579901. Inclusion in this directory is not an endorsement.