Clinical Trial to Evaluate the Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) in Women Aged 22 and Over With Breast Reconstruction or Augmentation Mammoplasty.

Seoul National University Hospital2 sites in 1 country103 target enrollmentOctober 30, 2010

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Seoul National University Hospital
Enrollment: 103
Locations: 2
Primary Endpoint: a rate of rupture of 1%
Status: Active, not recruiting
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or augmentation

Registry

clinicaltrials.gov

Start Date

October 30, 2010

End Date

December 30, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Over 22 years of age
•Subjects who want breast augmentation reconstruction following breast cancer, congenital or accidental unbalanced breast size
•Negative pregnancy test in fertile women
•Subjects who voluntarily decided the participation of the study and signed the informed consent
•Subjects who can understand and comply with the instructions and participate during the entire period of the trial

Exclusion Criteria

•previous breast reconstruction or augmentation history
•self -immune disease
•uncontrolled active infectious disease
•unable to insert beast implant due to radiotherapy
•Patients who have recurrent breast cancer or do not treat effectively their cancer
•Abnormal blood test or ECG result for general anesthesia
•Patients who cannot MRI scan due to having Metallic substance in the body or Claustrophobia
•Aesthetic addiction, drug abuse, alcohol abuse
•Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator

Outcomes

Primary Outcomes

a rate of rupture of 1%

Time Frame: 2 years

All the subjects have been monitored for 2 years and will be checked MRI to define rupture at 6month, 1 year and 2year after the breast implant.

a rate of capsular contracture of 5%

Time Frame: 2 years

The Baker classification that divided into 4 stages will be used as a reference to evaluate the capsular contracture. Only stage 3 and 4 will be confirmed as capsular contracture.