Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant

Sponsor

Seoul National University Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01711710

Collaborator

HansBiomed Co.,Ltd. (Industry)

103

Enrollment

Locations

Arm

146

Duration (Months)

51.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: Cohesive Gel Breast Implant	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

103 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

Oct 30, 2010

Actual Primary Completion Date :

Oct 30, 2014

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohesive Gel Breast Implant Cohesive Silicone Gel-Filled Breast Implant	Device: Cohesive Gel Breast Implant 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. Other Names: Cohesive Silicone Gel-Filled Breast Implant(CoSBI)

Arm

Intervention/Treatment

Experimental: Cohesive Gel Breast Implant

Cohesive Silicone Gel-Filled Breast Implant

Device: Cohesive Gel Breast Implant

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.

Other Names:

Cohesive Silicone Gel-Filled Breast Implant(CoSBI)

Outcome Measures

Primary Outcome Measures

a rate of rupture of 1% [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% [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.

Secondary Outcome Measures

a rate of connective tissue disease [2 years]
Connective tissue disease include hair loss, erythema, photosensitivity, dry eye syndrome,myalgia,neuralgia,arthralgia, etc.
Changes in bust girth and actual measured bra-cup size [2 years]
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.
Change in life satisfaction [2 years]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

22 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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