Trials / Unknown
UnknownNCT01639053
Sientra Post-Approval Study
U.S. Postapproval Study of Sientra Silicone Gel Breast Implants
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 5,498 (actual)
- Sponsor
- Tiger Biosciences, LLC. · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
This is a ten-year postapproval study to evaluate the long-term clinical performance of Sientra Silicone Gel Breast Implants under general conditions of use in the postmarket environment.
Conditions
Timeline
- Start date
- 2012-04-01
- Primary completion
- 2025-03-01
- Completion
- 2025-03-01
- First posted
- 2012-07-12
- Last updated
- 2023-05-03
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01639053. Inclusion in this directory is not an endorsement.