Trials / Recruiting
RecruitingNCT06938399
Motiva Implants® Post-Approval Study
Motiva Implants® Post-Approval Study (PAS) Protocol for Motiva SmoothSilk® Round Ergonomix® ('Ergonomix®') and SmoothSilk® Round ('Round') Breast Implants in Subjects Who Are Undergoing Primary Breast Augmentation, Revision Augmentation and Other Aesthetic Procedures
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2,400 (estimated)
- Sponsor
- Motiva USA LLC · Industry
- Sex
- Female
- Age
- 22 Years
- Healthy volunteers
- Accepted
Summary
This study examines the general post-market use and safety of Motiva Implants® and gathers and assesses selected safety and effectiveness data about their post market performance and experience.
Detailed description
Prospective, non-randomized, multicenter study including baseline (preoperative), operative, and postoperative data collection annually Years 1-10.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Silicone gel-filled breast implants - Motiva Implants® | Breast Surgery |
| OTHER | Aesthetic Surgery | Aesthetic procedure other than breast implant surgery |
Timeline
- Start date
- 2025-05-01
- Primary completion
- 2037-04-01
- Completion
- 2037-07-31
- First posted
- 2025-04-22
- Last updated
- 2026-03-27
Locations
29 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06938399. Inclusion in this directory is not an endorsement.