Study of the Safety and Effectiveness of Motiva Implants®
NCT03579901 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800
Last updated 2025-11-12
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.
Conditions
- Breast Implants
Interventions
- DEVICE
-
Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants
Breast augmentation
Sponsors & Collaborators
-
Motiva USA LLC
lead INDUSTRY
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2018-04-06
- Primary Completion
- 2032-08-30
- Completion
- 2033-02-28
- FDA Device
- Yes
Countries
- United States
- Germany
- Sweden
Study Locations
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