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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 20, 2014