Post Market Clinical Experience Study of Sientra 207 Breast Implants

Last updated: May 2, 2019
Sponsor: Sientra, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Reconstruction

Treatment

N/A

Clinical Study ID

NCT02905617
CP-1008
  • Ages > 22
  • Female
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

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

Exclusion

Exclusion Criteria:

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

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

Study Design

Total Participants: 180
Study Start date:
August 01, 2016
Estimated Completion Date:
December 31, 2020

Connect with a study center

  • Sientra, Inc.

    Santa Barbara, California 93117
    United States

    Active - Recruiting

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