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

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.

Study Overview

• Status: Terminated
• Conditions: Breast Augmentation
• Intervention / Treatment: Device: UNIGEL Silicone Gel-Filled Breast Implant

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Breast Augmentation	Device: UNIGEL Silicone Gel-Filled Breast Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
a rate of rupture of 4%	2 years
a rate of capsular contracture of 10%	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Kaplan-Meier Analysis of rupture or capsular contracture events	2 years
Change in nipple sensitivity	2 years
a rate of adverse evnets	2 years
Change in chest, bust and under bust circumference	2 years
SF-36(Short Form (36) Health Survey ), Evaluation of quality of life	2 years

Collaborators and Investigators

• Sponsor: Sewoon Medical Co., Ltd
• Collaborators: Samsung Medical Center; Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2015
• Primary Completion (ACTUAL): April 23, 2021
• Study Completion (ACTUAL): April 23, 2021

Study Registration Dates

• First Submitted: October 6, 2015
• First Submitted That Met QC Criteria: October 6, 2015
• First Posted (ESTIMATE): October 8, 2015

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Protocol Approval No. 534