Sientra Post-Approval Study
NCT01639053 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 5498
Last updated 2023-05-03
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
- Breast Augmentation
- Breast Reconstruction
- Breast Revision
Sponsors & Collaborators
-
Tiger Biosciences, LLC.
lead INDUSTRY
Principal Investigators
-
Sientra, Inc. · Sponsor GmbH
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-04-30
- Primary Completion
- 2025-03-31
- Completion
- 2025-03-31
Countries
- United States
Study Locations
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