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

Sponsor
Sewoon Medical Co., Ltd (Industry)
Overall Status
Terminated
CT.gov ID
NCT02571751
Collaborator
Seoul National University Bundang Hospital (Other), Samsung Medical Center (Other)
69
Enrollment
1
Location
1
Arm
68.7
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: UNIGEL Silicone Gel-Filled Breast Implant
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
69 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Actual Study Start Date :
Aug 1, 2015
Actual Primary Completion Date :
Apr 23, 2021
Actual Study Completion Date :
Apr 23, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Breast Augmentation

Device: UNIGEL Silicone Gel-Filled Breast Implant

Outcome Measures

Primary Outcome Measures

  1. a rate of rupture of 4% [2 years]

  2. a rate of capsular contracture of 10% [2 years]

Secondary Outcome Measures

  1. Kaplan-Meier Analysis of rupture or capsular contracture events [2 years]

  2. Change in nipple sensitivity [2 years]

  3. a rate of adverse evnets [2 years]

  4. Change in chest, bust and under bust circumference [2 years]

  5. SF-36(Short Form (36) Health Survey ), Evaluation of quality of life [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Seoul National University Bundang Hospital Seongnam Gyeonggi-do Korea, Republic of

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sewoon Medical Co., Ltd
ClinicalTrials.gov Identifier:
NCT02571751
Other Study ID Numbers:
  • Protocol Approval No. 534
First Posted:
Oct 8, 2015
Last Update Posted:
Sep 28, 2021
Last Verified:
Sep 1, 2021

Study Results

No Results Posted as of Sep 28, 2021