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| ID | Type | Description | Link |
|---|---|---|---|
| E-1005-049-001 | Other Identifier | IRB |
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| Name | Class |
|---|---|
| HansBiomed Co.,Ltd. | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohesive Gel Breast Implant | Experimental | Cohesive Silicone Gel-Filled Breast Implant |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cohesive Gel Breast Implant | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chanyeong Heo, Ph. D | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Seongnam-si | Gyeonggi-do | 463-707 | South Korea | ||
| Samsung Medical Center |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D012421 | Rupture |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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 |
| Seoul |
| 135-710 |
| South Korea |
| D017437 |
| Skin and Connective Tissue Diseases |
| D014947 | Wounds and Injuries |