Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Device: Cohesive Gel Breast Implant

• Registration Number: NCT01711710
• Lead Sponsor: Seoul National University Hospital

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-10-30
• Study First Submitted: 2012-10-18
• Study First Submitted QC: 2012-10-18
• Study First Posted: 2012-10-22
• Primary Completion: 2014-10-30
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-04
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 103

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohesive Gel Breast Implant	Cohesive Gel Breast Implant	Cohesive Silicone Gel-Filled Breast Implant

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
a rate of connective tissue disease	2 years	Connective tissue disease include hair loss, erythema, photosensitivity, dry eye syndrome,myalgia,neuralgia,arthralgia, etc.
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
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.

Trial Locations

Locations (2)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Gyeonggi-do, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of