Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant

Seoul National University

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Device: Cohesive Gel Breast Implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01711710

E-1005-049-001 (Other Identifier)

06-2010-095

Details and patient eligibility

About

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

Enrollment: 103 patients

Sex: Female

Ages: 22+ years old

Volunteers: Accepts Healthy Volunteers

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
• Keloid
• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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103 participants in 1 patient group

Cohesive Gel Breast Implant

Experimental group

Description:

Cohesive Silicone Gel-Filled Breast Implant

Treatment:

Device: Cohesive Gel Breast Implant