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

Sewoon Medical

Status: Terminated

Conditions: Breast Augmentation

Treatments: Device: UNIGEL Silicone Gel-Filled Breast Implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02571751

Protocol Approval No. 534

Details and patient eligibility

About

Open-label, Multi-center, Clinical trial to Evaluate Safety and Efficacy of Cohesive Gel-Filled Breast Implants UNIGEL® Targeting of Women from 22 to 60 Aged with regard to Augmentation Mammaplasty for Purpose of Cosmetic Surgery.

Enrollment: 69 patients

Sex: Female

Ages: 22 to 60 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

69 participants in 1 patient group

Breast Augmentation

Experimental group

Treatment:

Device: UNIGEL Silicone Gel-Filled Breast Implant