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Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00905645
Recruitment Status : Active, not recruiting
First Posted : May 20, 2009
Last Update Posted : June 15, 2018
Sponsor:
Information provided by (Responsible Party):
Sientra, Inc.

Brief Summary:
Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.

Condition or disease Intervention/treatment Phase
Breast Augmentation Breast Reconstruction Breast Revision Device: Silimed Gel-Filled Mammary Implant Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1788 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation
Study Start Date : November 2002
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Primary Augmentation
Silimed Gel-Filled Mammary Implant
Device: Silimed Gel-Filled Mammary Implant
Experimental: Primary Reconstruction
Silimed Gel-Filled Mammary Implant
Device: Silimed Gel-Filled Mammary Implant
Experimental: Revison
Silimed Gel-Filled Mammary Implant
Device: Silimed Gel-Filled Mammary Implant



Primary Outcome Measures :
  1. Local complications [ Time Frame: 10 Years ]

Secondary Outcome Measures :
  1. Satisfaction determined by patients [ Time Frame: 10 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Subjects are admitted into the study only if all of the following eligibility is true:

  • Female
  • Age limitation specific to the indication:

    • Primary Augmentation: Must be 18 years or older
    • Primary Reconstruction: No age limit
    • Revision: If original surgery was primary reconstruction, then no age limit. If original surgery was primary augmentation, then must be 18 years or older.
  • Adequate tissue available to cover implant(s)
  • Willingness to follow study requirements (informed consent form, follow-up visits)
  • Candidate for primary augmentation, primary reconstruction, or revision

Exclusion Criteria

Subjects are not eligible if any of the following criteria exist:

  • Advanced fibrocystic disease, considered to be pre-malignant without mastectomy
  • Inadequate or unsuitable tissue
  • Active infection in the body at the time of surgery
  • Pregnant or lactating
  • Medical condition that might result in unduly high surgical risk and/or significant postoperative complications, in the judgment of the Investigator
  • Use of drugs, including any drug that would interfere with blood clotting, that might result in high risk and/or significant postoperative complications
  • Demonstrated psychological characteristics that are unrealistic or unreasonable given the risks involved with the surgical procedure
  • Determination by physical examination that the subject does have any connective tissue/autoimmune disorder
  • Existing carcinoma of the breast without accompanying mastectomy
  • MRI scan is prohibited because of implanted metal device, claustrophobia, or other condition.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905645


Locations
United States, California
Sientra, Inc.
Santa Barbara, California, United States, 93117
Sponsors and Collaborators
Sientra, Inc.

Publications:
Responsible Party: Sientra, Inc.
ClinicalTrials.gov Identifier: NCT00905645     History of Changes
Other Study ID Numbers: G010193
First Posted: May 20, 2009    Key Record Dates
Last Update Posted: June 15, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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