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Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Sientra, Inc.
ClinicalTrials.gov Identifier:
NCT00905645
First received: May 18, 2009
Last updated: NA
Last verified: May 2009
History: No changes posted
  Purpose

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 Intervention Phase
Breast Augmentation
Breast Reconstruction
Breast Revision
 Device: Silimed Gel-Filled Mammary Implant
 Phase 3

Sientra, Inc. has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sientra, Inc.:

Primary Outcome Measures:
  • Local complications [ Time Frame: 10 Years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Satisfaction determined by patients [ Time Frame: 10 Years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: November 2002
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Primary Augmentation Device: Silimed Gel-Filled Mammary Implant
Experimental: Primary Reconstruction Device: Silimed Gel-Filled Mammary Implant
Experimental: Revison Device: Silimed Gel-Filled Mammary Implant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905645

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

No publications provided

Responsible Party: Rosalyn d'Incelli/Vice President Clinical Operations, Sientra, Inc
ClinicalTrials.gov Identifier: NCT00905645     History of Changes
Other Study ID Numbers: G010193
Study First Received: May 18, 2009
Last Updated: May 18, 2009
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013