Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

Not Applicable

Completed

• Conditions: Breast Reconstruction; Breast Augmentation; Breast Revision
• Interventions: Device: Silimed Gel-Filled Mammary Implant

• Registration Number: NCT00905645
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-11
• Study First Submitted: 2009-05-18
• Study First Submitted QC: 2009-05-18
• Study First Posted: 2009-05-20
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2023-09
• Results First Submitted: 2023-12-18
• Results First Submitted QC: 2023-12-18
• Last Update Submitted: 2023-12-18
• Results First Posted: 2024-01-11
• Last Update Posted: 2024-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1788

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Revision-Augmentation	Silimed Gel-Filled Mammary Implant	Silimed Gel-Filled Mammary Implant
Primary Reconstruction	Silimed Gel-Filled Mammary Implant	Silimed Gel-Filled Mammary Implant
Revision-Reconstruction	Silimed Gel-Filled Mammary Implant	Silimed Gel-Filled Mammary Implant
Primary Augmentation	Silimed Gel-Filled Mammary Implant	Silimed Gel-Filled Mammary Implant

Primary Outcome Measures

Name	Time	Method
Local Complications	10 Years	Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years.

Secondary Outcome Measures

Name	Time	Method
Satisfaction Determined by Patients	10 Years	Assessment of the effectiveness of Study Implants based on patient satisfaction using a 5-point scale where 1=strongly agree to 5= strongly disagree. The patient satisfaction measures through 10 years provided in the table below are based on questionnaire responses of "Strongly Agree" and "Agree."

Trial Locations

Locations (1)

Sientra, Inc.; 🇺🇸 Santa Barbara, California, United States