Sientra Post-Approval Study

April 29, 2023 updated by: Sientra, Inc.

U.S. Postapproval Study of Sientra Silicone Gel Breast Implants

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

5498

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93117
        • Sientra, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Women who receive Sientra Silicone Gel Breast Implants for augmentation, revision augmentation, reconstruction, and revision reconstruction. Control participants are candidates for and undergo aesthetic surgery other than implantation with Silicone Gel Breast implants.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Gel Participants
Control Participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Long-term safety of Sientra Silicone Gel Breast Implants in women
Time Frame: 10-years
10-years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sientra, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Anticipated)

March 1, 2025

Study Completion (Anticipated)

March 1, 2025

Study Registration Dates

First Submitted

July 10, 2012

First Submitted That Met QC Criteria

July 11, 2012

First Posted (Estimate)

July 12, 2012

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 29, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CP-1007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Augmentation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Macedonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe