Overview

This trial is active, not recruiting.

Conditions breast augmentation, breast reconstruction, breast revision
Sponsor Sientra, Inc.
Start date April 2012
End date March 2025
Trial size 5000 participants
Trial identifier NCT01639053, CP-1007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm

Primary Outcomes

Measure
Long-term safety of Sientra Silicone Gel Breast Implants in women
time frame: 10-years

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title U.S. Postapproval Study of Sientra Silicone Gel Breast Implants
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Sientra, Inc..