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Sientra Post-Approval Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01639053
Recruitment Status : Active, not recruiting
First Posted : July 12, 2012
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease
Breast Augmentation Breast Reconstruction Breast Revision

Study Design

Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: U.S. Postapproval Study of Sientra Silicone Gel Breast Implants
Study Start Date : April 2012
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2025

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Gel Participants
Control Participants


Outcome Measures

Primary Outcome Measures :
  1. Long-term safety of Sientra Silicone Gel Breast Implants in women [ Time Frame: 10-years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
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.
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01639053


Locations
United States, California
Sientra, Inc.
Santa Barbara, California, United States, 93117
Sponsors and Collaborators
Sientra, Inc.
Investigators
Study Director: Sientra, Inc. Sponsor GmbH
More Information

Responsible Party: Sientra, Inc.
ClinicalTrials.gov Identifier: NCT01639053     History of Changes
Other Study ID Numbers: CP-1007
First Posted: July 12, 2012    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Sientra, Inc.:
Breast Augmentation
Breast Reconstruction
Breast Revision
Silicone breast implants