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

NCT ID: NCT02571751

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2021-04-23

Brief Summary

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.

Conditions

Breast Augmentation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Breast Augmentation

Group Type: EXPERIMENTAL

UNIGEL Silicone Gel-Filled Breast Implant

Intervention Type: DEVICE

Interventions

UNIGEL Silicone Gel-Filled Breast Implant

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: collaborator

Samsung Medical Center

OTHER

Sponsor Role: collaborator

Sewoon Medical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Countries

South Korea

Other Identifiers

Protocol Approval No. 534

Identifier Type: -

Identifier Source: org_study_id