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Clinical Trials in the USA / NCT01639053
Active, not recruiting Observational

Sientra Post-Approval Study

NCT01639053 · tracked via the Priya Life Science USA tracker
Sponsor
Tiger Biosciences, LLC
Phase
Observational
Started
2012-04
Last updated
2026-09-22

Condition(s) studied

Breast AugmentationBreast ReconstructionBreast Revision

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: 1. Genetic female with US residency 2. Is at least 18 years old for primary or revision reconstruction or 22 years old for primary or revision augmentation 3. Agrees to Sientra study requirements Exclusion Criteria: 1. Has an active infection anywhere in body 2. Has active cancer without adequate treatment 3. Currently pregnant or nursing 4. Has any condition or diagnosis that, in the investigator's opinion, would negatively affect ability to complete study requirements 5. If control participant, has undergone breast implant surgery with silicone gel-filled breast implants

Primary outcome measure(s)

  • Long-term safety of Sientra Silicone Gel Breast Implants in women — 10-years

Trial sites (1)

FacilityCityRegionStatus
Sientra, Inc. Santa Barbara California

More Tiger Biosciences, LLC. trials in the USA

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Other trials for the same condition

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A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction Active, not recruiting
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Effectiveness and Safety of OviTex® PRS in Breast Reconstruction Recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT01639053 on ClinicalTrials.gov ↗ ← All trials in the USA