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

NCT02571751 | Terminated

• 1 other identifier: Protocol Approval No. 534
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• a rate of rupture of 4%

  2 years

• a rate of capsular contracture of 10%

  2 years

Secondary Outcomes (5)

• 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

Study Arms (1)

Breast Augmentation

EXPERIMENTAL

Device: UNIGEL Silicone Gel-Filled Breast Implant

Interventions

UNIGEL Silicone Gel-Filled Breast Implant DEVICE

Breast Augmentation

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sewoon Medical Co., Ltd: lead
• Seoul National University Bundang Hospital: collaborator
• Samsung Medical Center: collaborator

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 8, 2015
• Study Start: August 1, 2015
• Primary Completion: April 23, 2021
• Study Completion: April 23, 2021
• Last Updated: September 28, 2021

Record last verified: 2021-09

Locations

KR (1)