Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant

NCT01711710 | Unknown

• 2 other identifiers: 06-2010-095E-1005-049-001
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 2

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

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• a rate of connective tissue disease

  2 years

• Changes in bust girth and actual measured bra-cup size

  2 years

• Change in life satisfaction

  2 years

Study Arms (1)

Cohesive Gel Breast Implant

EXPERIMENTAL

Cohesive Silicone Gel-Filled Breast Implant

Device: Cohesive Gel Breast Implant

Interventions

Cohesive Gel Breast Implant DEVICE

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.

Also known as: Cohesive Silicone Gel-Filled Breast Implant(CoSBI)

Cohesive Gel Breast Implant

Eligibility Criteria

• Age: 22 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• HansBiomed Co.,Ltd.: collaborator

Study Sites (2)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms; Rupture

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Wounds and Injuries

Study Officials

• Chanyeong Heo, Ph. D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2012
• First Posted: October 22, 2012
• Study Start: October 30, 2010
• Primary Completion: October 30, 2014
• Study Completion: December 30, 2022
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

KR (2)