Last updated on September 2018

Open-label Multi-center Trial to Evaluate Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implants UNIGEL

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Breast Augmentation
  • Age: Between 22 - 60 Years
  • Gender: Female

Inclusion Criteria:

  • Has given written informed consent to entry
  • Female, 22 years to 60 years
  • Breast augmentation(cosmetic surgery) is for following subjects
  • Who is not content with breast size and shape
  • Who has congenital asymmetrical deformity
  • subject who agree to MRI scan during the trial
  • subject who agree to visit to hospital according to schedule specified in the protocol during the entire period of the trial

Exclusion Criteria:

  • Pregnant or lactating women and women of childbearing age
  • Subject who has operation history of breast augmentation or reconstruction
  • Subject who has fibrocystic Breast Disease coming up for precancerous lesion not accompanied with subcutaneous mastectomy
  • Subject who has breast cancer or prodromal phase and no proper treatment.
  • Subject who is diagnosed with Breast Imaging-Reporting and Data System(BI-RADS) category 3 under breast ultrasonography.
  • Subject who has uncontrolled active infectious disease or abscess
  • Autoimmune disease
  • Diabetes mellitus
  • Keloidosis
  • Subject who cannot take general anesthesia due to abnormal blood or ECG results.
  • Subject who is not appropriate for breast augmentation due to damaged tissue or blood vessel or ulcer
  • Subject who has metal materials in a body such as ventricular assist system or cerebral aneurysm clips, or has claustrophobia (not suitable for MRI SCAN)
  • Physically/mentally disabled subject that may disturb understanding and cooperation for the trial.
  • Any other conditions that may interfere with correct assessment of the trial.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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