Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant

Study Overview
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Brief Summary
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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

Official Title
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Cohesive Gel Breast Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohesive Gel Breast Implant<br>Cohesive Silicone Gel-Filled Breast Implant | Device: Cohesive Gel Breast Implant<br>* Cohesive Silicone Gel-Filled Breast Implant insert under the submuscular with axillary incision in breast augmentation mammoplasty. Remove tissue expander and insert Cohesive Silicone Gel-Filled Breast Implant in breast reconstruction.<br>* Other names: Cohesive Silicone Gel-Filled Breast Implant(CoSBI);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a rate of rupture of 1% | 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. | 2 years | 
| a rate of capsular contracture of 5% | 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. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| a rate of connective tissue disease | Connective tissue disease include hair loss, erythema, photosensitivity, dry eye syndrome,myalgia,neuralgia,arthralgia, etc. | 2 years | 
| Changes in bust girth and actual measured bra-cup size | Bra cup size can be determined by measuring right or left bust circumference over the nipple. 6 inch= doubleA, 7inch=A, 8inch= B, 9inch=C, 10inch=D, 11inch=E Bust girth means bust circumference line . It can be determined by measuring around the women's torso over the fullest part of the breasts. | 2 years | 
| Change in life satisfaction | The subject questionaire including Rosenberg Self Esteem Scale,Body Esteem Scale,Survey of Functional-36 Status Survey will be assessed at 6month, 1year and 2year after the intervention | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, reconstruction, augmentation, cohesive silicone gel, breast implant, rupture, capsular contracture