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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.


N/A
22 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

a rate of rupture of 1%

Outcome 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.

Outcome Time Frame:

2 years

Safety Issue:

Yes

Principal Investigator

Chanyeong Heo, Ph. D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Seoul National University Hospital

Authority:

Korea: Food and Drug Administration

Study ID:

06-2010-095

NCT ID:

NCT01711710

Start Date:

October 2010

Completion Date:

November 2014

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • reconstruction
  • augmentation
  • cohesive silicone gel
  • breast implant
  • rupture
  • capsular contracture
  • Breast Neoplasms

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