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Post Market Clinical Experience Study of Sientra 207 Breast Implants

Sponsor
Sientra, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT02905617
Collaborator
(none)
180
Enrollment
1
Location
52
Duration (Months)
3.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A 12-month study to evaluate the clinical experience with Sientra 207 Silicone Gel Breast Implants

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    180 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Post Market Clinical Experience Study of the Sientra 207 High-Strength Cohesive Plus (HSC+) Breast Implants in Primary and Revision Augmentation Participants
    Study Start Date :
    Aug 1, 2016
    Anticipated Primary Completion Date :
    Dec 1, 2020
    Anticipated Study Completion Date :
    Dec 1, 2020

    Arms and Interventions

    Arm Intervention/Treatment
    Primary Augmentation
    Revision Augmentation

    Outcome Measures

    Primary Outcome Measures

    1. Investigator Overall Satisfaction Questionnaire [3 months]

    2. Investigator Overall Satisfaction Questionnaire [6 months]

    3. Investigator Overall Satisfaction Questionnaire [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    22 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Is a candidate for primary or revision breast augmentation and is at least 22 years of age,

    2. Agrees to Sientra study requirements and to comply with office follow-up visits at months 3, 6 and 12.

    Exclusion Criteria:

    1. Does not meet the Investigator's standard eligibility for breast augmentation or revision surgery

    2. Surgeon is planning to use acellular dermal matrix (ADM) or surgical mesh and/or recommend postoperative massage.

    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:
    NCT02905617
    Other Study ID Numbers:
    • CP-1008
    First Posted:
    Sep 19, 2016
    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 Revision-Augmentation

    Study Results

    No Results Posted as of May 6, 2019