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Sientra Post-Approval Study

This study is currently recruiting participants.
Verified July 2012 by Sientra, Inc.
Sponsor:
Information provided by (Responsible Party):
Sientra, Inc.
ClinicalTrials.gov Identifier:
NCT01639053
First received: July 10, 2012
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Breast Augmentation
Breast Reconstruction
Breast Revision

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: U.S. Postapproval Study of Sientra Silicone Gel Breast Implants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sientra, Inc.:

Estimated Enrollment: 5000
Study Start Date: April 2012
Estimated Study Completion Date: December 2023
Groups/Cohorts
Gel Participants
Control Participants

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01639053

Contacts
Contact: Sientra, Inc

Locations
United States, California
Sientra, Inc. Recruiting
Santa Barbara, California, United States, 93117
Contact: Sientra, Inc     888-708-0808        
Sponsors and Collaborators
Sientra, Inc.
Investigators
Study Director: Sientra, Inc. Sponsor GmbH
  More Information

No publications provided

Responsible Party: Sientra, Inc.
ClinicalTrials.gov Identifier: NCT01639053     History of Changes
Other Study ID Numbers: CP-1007
Study First Received: July 10, 2012
Last Updated: July 11, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013