NCT01639053

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
5,498

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 10, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 12, 2012

Completed
12.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 3, 2023

Status Verified

April 1, 2023

Enrollment Period

12.9 years

First QC Date

July 10, 2012

Last Update Submit

April 29, 2023

Conditions

Breast AugmentationBreast ReconstructionBreast Revision

Keywords

Breast AugmentationBreast ReconstructionBreast RevisionSilicone breast implants

Outcome Measures

Primary Outcomes (1)

  • Long-term safety of Sientra Silicone Gel Breast Implants in women

    10-years

Study Arms (2)

Gel Participants

Control Participants

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Genetic female with US residency
  • Is at least 18 years old for primary or revision reconstruction or 22 years old for primary or revision augmentation
  • Agrees to Sientra study requirements

You may not qualify if:

  • Has an active infection anywhere in body
  • Has active cancer without adequate treatment
  • Currently pregnant or nursing
  • Has any condition or diagnosis that, in the investigator's opinion, would negatively affect ability to complete study requirements
  • If control participant, has undergone breast implant surgery with silicone gel-filled breast implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sientra, Inc.

Santa Barbara, California, 93117, United States

Location

Study Officials

  • Sientra, Inc.

    Sponsor GmbH

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2012

First Posted

July 12, 2012

Study Start

April 1, 2012

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

May 3, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)