Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant (NCT01711710) | Clinical Trial Compass
UnknownNot Applicable
Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant
South Korea103 participantsStarted 2010-10-30
Plain-language 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
Who can participate
Age range22 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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