Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant
NCT ID: NCT01711710
Last Updated: 2022-11-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
103 participants
INTERVENTIONAL
2010-10-30
2022-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Cohesive Gel Breast Implant
Cohesive Silicone Gel-Filled Breast Implant
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
22 Years
FEMALE
Yes
Sponsors
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HansBiomed Co.,Ltd.
INDUSTRY
Seoul National University Hospital
OTHER
Responsible Party
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Principal Investigators
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Chanyeong Heo, Ph. D
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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E-1005-049-001
Identifier Type: OTHER
Identifier Source: secondary_id
06-2010-095
Identifier Type: -
Identifier Source: org_study_id
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