Clinical trial · Interventional
Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant
Clinical Trial to Evaluate the Safety and Efficacy of Cohesive Silicone Gel-Filled Breast Implant (CoSBI) in Women Aged 22 and Over With Breast Reconstruction or Augmentation Mammoplasty.
NCT01711710CI-TRIAL-00061953unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cohesive Gel Breast Implant | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cohesive Gel Breast Implant
- description
- Cohesive Silicone Gel-Filled Breast Implant
- interventionNames
- Device: Cohesive Gel Breast Implant
Primary outcomes (2)
- measure
- a rate of rupture of 1%
- timeFrame
- 2 years
- description
- All the subjects have been monitored for 2 years and will be checked MRI to define rupture at 6month, 1 year and 2year after the breast implant.
- measure
- a rate of capsular contracture of 5%
- timeFrame
- 2 years
- description
- The Baker classification that divided into 4 stages will be used as a reference to evaluate the capsular contracture. Only stage 3 and 4 will be confirmed as capsular contracture.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Over 22 years of age * Subjects who want breast augmentation reconstruction following breast cancer, congenital or accidental unbalanced breast size * Negative pregnancy test in fertile women * Subjects who voluntarily decided the participation of the study and signed the informed consent * Subjects who can understand and comply with the instructions and participate during the entire period of the trial Exclusion Criteria: * previous breast reconstruction or augmentation history * self -immune disease * uncontrolled active infectious disease * unable to insert beast implant due to radiotherapy * Patients who have recurrent breast cancer or do not treat effectively their cancer * Keloid * Abnormal blood test or ECG result for general anesthesia * Patients who cannot MRI scan due to having Metallic substance in the body or Claustrophobia * Aesthetic addiction, drug abuse, alcohol abuse * Patients who are not eligible for this study at the medical discretion of the Principal Investigator or Sub-investigator
References
Publications (0)
Data not yet available
No reference posted for this study.