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.

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01711710

Enrollment

103

Registered

2012-10-22

Start date

2010-10-30

Completion date

2022-12-30

Last updated

2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast cancer, reconstruction, augmentation, cohesive silicone gel, breast implant, rupture, capsular contracture

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

Interventions

DEVICECohesive 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

22 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026