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

Breast Augmentation Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02571751
• Other study ID #: Protocol Approval No. 534
• Status: Terminated
• Phase: N/A
• Start date: August 2015
• Est. completion date: April 23, 2021

Study information

• Verified date: September 2021
• Source: Sewoon Medical Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 69
• Est. completion date: April 23, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 22 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Augmentation

Intervention

Device:
• UNIGEL Silicone Gel-Filled Breast Implant

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi-do

Sponsors (3)

Lead Sponsor	Collaborator
Sewoon Medical Co., Ltd	Samsung Medical Center, Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a rate of rupture of 4%		2 years
Primary	a rate of capsular contracture of 10%		2 years
Secondary	Kaplan-Meier Analysis of rupture or capsular contracture events		2 years
Secondary	Change in nipple sensitivity		2 years
Secondary	a rate of adverse evnets		2 years
Secondary	Change in chest, bust and under bust circumference		2 years
Secondary	SF-36(Short Form (36) Health Survey ), Evaluation of quality of life		2 years