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NCT01639053 Clinical Trial

Sientra Post-Approval Study

Breast Reconstruction Clinical Trial

Official title:
U.S. Postapproval Study of Sientra Silicone Gel Breast Implants

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01639053
Other study ID # CP-1007
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 2012
Est. completion date March 2025

Study information
Verified date April 2023
Source Sientra, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 5498
Est. completion date March 2025
Est. primary completion date March 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Sientra, Inc. Santa Barbara California

Sponsors (1)
Lead Sponsor Collaborator
Sientra, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Long-term safety of Sientra Silicone Gel Breast Implants in women 10-years
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