Breast CancerNCT01711710
Clinical Trial to Evaluate the Safety and Efficacy of Breast Implant
A study testing Cohesive Gel Breast Implant in people with Breast Cancer, run by Seoul National University Hospital at 2 sites in South Korea.
Trial 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 Read more about this study
- Who is it for?
- Ages 22 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cohesive Gel Breast Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 30 Oct 2010to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Samsung Medical Center
Seoul, 135-710
About this study
Official title: 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.
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
- Breast Cancer
- Being tested
- Cohesive Gel Breast Implant
- Keywords
- Breast cancer, reconstruction, augmentation, cohesive silicone gel, breast implant, rupture, capsular contracture
- Medical subject headings
- Breast Neoplasms, Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cohesive Gel Breast ImplantDevice
Also called Cohesive Silicone Gel-Filled Breast Implant(CoSBI)
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohesive Gel Breast Implant | Experimental | Cohesive Silicone Gel-Filled Breast Implant Receives: Device: Cohesive Gel Breast Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
a rate of rupture of 1%
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.
Measured: 2 years
a rate of capsular contracture of 5%
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.
Measured: 2 years
Secondary outcomes (3)
a rate of connective tissue disease
Connective tissue disease include hair loss, erythema, photosensitivity, dry eye syndrome,myalgia,neuralgia,arthralgia, etc.
Measured: 2 years
Changes in bust girth and actual measured bra-cup size
Bra cup size can be determined by measuring right or left bust circumference over the nipple.
6 inch= doubleA, 7inch=A, 8inch= B, 9inch=C, 10inch=D, 11inch=E Bust girth means bust circumference line . It can be determined by measuring around the women's torso over the fullest part of the breasts.
Measured: 2 years
Change in life satisfaction
The subject questionaire including Rosenberg Self Esteem Scale,Body Esteem Scale,Survey of Functional-36 Status Survey will be assessed at 6month, 1year and 2year after the intervention
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study start30 Oct 2010
- Primary completion30 Oct 2014
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- HansBiomed Co.,Ltd.
- Responsible party
- Sponsor
- Investigators
- Chanyeong Heo, Ph. D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711710
- Sponsor's protocol ID
- 06-2010-095
- Other IDs
- E-1005-049-001
- Status last verified
- Nov 2022
- First submitted
- 18 Oct 2012
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT01711710
- Acronym / sponsor ID
- 06-2010-095
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, reconstruction, augmentation, cohesive silicone gel, breast implant, rupture, capsular contracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- HansBiomed Co.,Ltd.
- Study start
- 30 Oct 2010
- Primary completion
- 30 Oct 2014 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 22 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohesive Gel Breast Implant | Experimental | Device: Cohesive Gel Breast ImplantCohesive Silicone Gel-Filled Breast Implant |
Who may qualify
- Ages
- 22 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cohesive Gel Breast ImplantAlso: Cohesive Silicone Gel-Filled Breast Implant(CoSBI)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. | Device | Cohesive Gel Breast Implant |
Primary outcome
a rate of rupture of 1%
Time frame: 2 years
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.
a rate of capsular contracture of 5%
Time frame: 2 years
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.
3 secondary outcomes
a rate of connective tissue disease
Time frame: 2 years
Changes in bust girth and actual measured bra-cup size
Time frame: 2 years
Change in life satisfaction
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chanyeong Heo, Ph. D principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cohesive Gel Breast Implant in people with Breast Cancer, run by Seoul National University Hospital at 2 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a rate of rupture of 1% (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.