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Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cohesive Gel Breast Implant
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Breast cancer, reconstruction, augmentation, cohesive silicone gel, breast implant, rupture, capsular contracture

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Bundang Hospital
  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohesive Gel Breast Implant

Arm Description

Cohesive Silicone Gel-Filled Breast Implant

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

a rate of connective tissue disease
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
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
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

Full Information

First Posted
October 18, 2012
Last Updated
November 2, 2022
Sponsor
Seoul National University Hospital
Collaborators
HansBiomed Co.,Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01711710
Brief Title
Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant
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 Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 30, 2010 (undefined)
Primary Completion Date
October 30, 2014 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seoul National University Hospital
Collaborators
HansBiomed Co.,Ltd.

4. Oversight

Data Monitoring Committee
No

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast cancer, reconstruction, augmentation, cohesive silicone gel, breast implant, rupture, capsular contracture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohesive Gel Breast Implant
Arm Type
Experimental
Arm Description
Cohesive Silicone Gel-Filled Breast Implant
Intervention Type
Device
Intervention Name(s)
Cohesive Gel Breast Implant
Other Intervention Name(s)
Cohesive Silicone Gel-Filled Breast Implant(CoSBI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
a rate of rupture of 1%
Description
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.
Time Frame
2 years
Title
a rate of capsular contracture of 5%
Description
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.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
a rate of connective tissue disease
Description
Connective tissue disease include hair loss, erythema, photosensitivity, dry eye syndrome,myalgia,neuralgia,arthralgia, etc.
Time Frame
2 years
Title
Changes in bust girth and actual measured bra-cup size
Description
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.
Time Frame
2 years
Title
Change in life satisfaction
Description
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
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chanyeong Heo, Ph. D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant

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