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Sientra Post-Approval Study

Sponsor
Sientra, Inc. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT01639053
Collaborator
(none)
5,498
Enrollment
1
Location
155
Duration (Months)
35.5
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    5498 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    U.S. Postapproval Study of Sientra Silicone Gel Breast Implants
    Study Start Date :
    Apr 1, 2012
    Anticipated Primary Completion Date :
    Mar 1, 2025
    Anticipated Study Completion Date :
    Mar 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Gel Participants
    Control Participants

    Outcome Measures

    Primary Outcome Measures

    1. Long-term safety of Sientra Silicone Gel Breast Implants in women [10-years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 Sientra, Inc. Santa Barbara California United States 93117

    Sponsors and Collaborators

    • Sientra, Inc.

    Investigators

    • Study Director: Sientra, Inc., Sponsor GmbH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sientra, Inc.
    ClinicalTrials.gov Identifier:
    NCT01639053
    Other Study ID Numbers:
    • CP-1007
    First Posted:
    Jul 12, 2012
    Last Update Posted:
    May 6, 2019
    Last Verified:
    May 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Sientra, Inc.
    Breast Augmentation
    Breast Reconstruction
    Breast Revision
    Silicone breast implants

    Study Results

    No Results Posted as of May 6, 2019