Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant

Breast Cancer Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01711710
• Other study ID #: 06-2010-095
• Secondary ID: E-1005-049-001
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 30, 2010
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 103
• Est. completion date: December 30, 2022
• Est. primary completion date: October 30, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	HansBiomed Co.,Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	a rate of connective tissue disease	Connective tissue disease include hair loss, erythema, photosensitivity, dry eye syndrome,myalgia,neuralgia,arthralgia, etc.	2 years
Secondary	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
Secondary	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