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Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant

NCT01711710 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2022-11-04

No results posted yet for this study

Summary

The aim of this study is to evaluate the safety and efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) produced by HansBiomed co.,Ltd. in breast reconstruction or augmentation

Conditions

Interventions

DEVICE

Cohesive Gel Breast Implant

Cohesive Silicone Gel-Filled Breast Implant insert under the submuscular with axillary incision in breast augmentation mammoplasty. Remove tissue expander and insert Cohesive Silicone Gel-Filled Breast Implant in breast reconstruction.

Sponsors & Collaborators

  • HansBiomed Co.,Ltd.

    collaborator INDUSTRY

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Chanyeong Heo, Ph. D · Seoul National University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-30
Primary Completion
2014-10-30
Completion
2022-12-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01711710 on ClinicalTrials.gov