Overview

This trial is active, not recruiting.

Conditions breast augmentation, breast reconstruction, breast revision
Treatment silimed gel-filled mammary implant
Phase phase 3
Sponsor Sientra, Inc.
Start date November 2002
End date December 2017
Trial size 1788 participants
Trial identifier NCT00905645, G010193

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Silimed Gel-Filled Mammary Implant
silimed gel-filled mammary implant
(Experimental)
Silimed Gel-Filled Mammary Implant
silimed gel-filled mammary implant
(Experimental)
Silimed Gel-Filled Mammary Implant
silimed gel-filled mammary implant

Primary Outcomes

Measure
Local complications
time frame: 10 Years

Secondary Outcomes

Measure
Satisfaction determined by patients
time frame: 10 Years

Eligibility Criteria

Female participants at least 18 years old.

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.

Additional Information

Official title Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Sientra, Inc..