Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Cohesive Gel Breast Implant

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: HansBiomed Co.,Ltd.
• Investigators: Principal Investigator: Chanyeong Heo, Ph. D, Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start: October 30, 2010
• Primary Completion (Actual): October 30, 2014
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: October 18, 2012
• First Submitted That Met QC Criteria: October 18, 2012
• First Posted (Estimate): October 22, 2012

Study Record Updates

• Last Update Posted (Actual): November 4, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Breast cancer; augmentation; reconstruction; rupture; breast implant; capsular contracture; cohesive silicone gel
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 06-2010-095; E-1005-049-001 (Other Identifier: IRB)