Breast Implant RuptureNCT02206282
Prevalence of Asymptomatic Rupture in SILIMED Breast Implants
An observational study of Breast Implant Rupture, run by Silimed Industria de Implantes Ltda.
Trial summary
A prospective clinical research is to assess the prevalence of implant rupture and presence of extracapsular gel in an un-referred population of women who have been implanted with the Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Implant Rupture
- How many people
- 390 participants
- Where
- No sites listed yet
- Study dates
- Aug 2006to Feb 2011
- Phase
- Observational
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 390 women (780 implants) from Rio de Janeiro and other Brazilian cities will be randomly selected to undergo MRI detection of asymptomatic rupture using a stratified sampling design, stratifying on implant age (time since implantation). Sixty-five (65) women will be selected from each of six implant age groups between 6-18 years.
Who may be able to join
- Female
- Subject implanted with the original Silimed gel-filled implant.
Who cannot join
- MR imaging is not possible because of the following:
- Metal implant
- Battery activated stimulator
- Pregnancy
- Tattoos
- Body weight >300 pounds
- History of metal fragments in the eye
- Any other contraindication to MR exam.
About this study
A prospective clinical research is to assess the prevalence of implant rupture and presence of extracapsular gel in an un-referred population of women who have been implanted with the Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.
- Conditions
- Breast Implant Rupture
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Image
390 Magnetic Resonance Images.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startAug 2006
- Primary completionNov 2010
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Implant RuptureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silimed Industria de Implantes Ltda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wanda Elizabeth Massiere Correa, MD, Principal investigator, Insituto Ivo Pitanguy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206282
- Sponsor's protocol ID
- IMR-LT-001
- Status last verified
- Jul 2014
- First submitted
- 28 Jul 2014
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Asymptomatic Rupture in SILIMED Breast Implants
- ClinicalTrials.gov ID
- NCT02206282
- Acronym / sponsor ID
- IMR-LT-001
- Conditions
- Breast Implant Rupture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Silimed Industria de Implantes LtdaIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 1 Aug 2014 (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.
A prospective clinical research is to assess the prevalence of implant rupture and presence of extracapsular gel in an un-referred population of women who have been implanted with the Silimed gel-filled mammary implants with or without any local or systemic systemic symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 390 women (780 implants) from Rio de Janeiro and other Brazilian cities will be randomly selected to undergo MRI detection of asymptomatic rupture using a stratified sampling design, stratifying on implant age (time since implantation). Sixty-five (65) women will be selected from each of six implant age groups between 6-18 years.
Key inclusion criteria (2 listed)
- Female
- Subject implanted with the original Silimed gel-filled implant.
Key exclusion criteria (8 listed)
- MR imaging is not possible because of the following:
- Metal implant
- Battery activated stimulator
- Pregnancy
- Tattoos
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Magnetic Resonance Image
Time frame: 1 year
390 Magnetic Resonance Images.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
Related trials for Breast Implant Rupture
RecruitingObservational study
Prospective Longitudinal Cohort Study of Implant Age, Pocket Plane, Incision, Surface Texture, and Volume as Predictors of Breast Implant Rupture
Breast Implant Rupture
RecruitingObservational study
Prospective Observational Clinical Follow-up of Euromi Biosciences Pre-filled Silicone Gel Breast Implants
Breast Implant Rupture, Breast Implant; Complications
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.
Wanda Elizabeth Massiere Correa, MD principal investigator
Insituto Ivo Pitanguy
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Implant Rupture, run by Silimed Industria de Implantes Ltda.
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 2 inclusion and 8 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: finished, as of the sponsor's last update on 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Magnetic Resonance Image (time frame: 1 year). 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 1 Aug 2014.