Breast AugmentationNCT01238601
Upright Magnetic Resonance Imaging (MRI) Study - Breast Implant Shell Geometry and Edge Scalloping
An observational study of Breast Augmentation, run by Ideal Implant Incorporated.
Trial summary
The purpose of this study is to determine how different types of breast implants contour to the chest wall. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women only
- Conditions the study is for
- Breast Augmentation
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to May 2010
- 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 20 to 50 years
- Women only
- Adult
Study population: Women 20-50 who previously had primary breast augmentation or replacement of existing breast implants.
Who may be able to join
- had previous primary breast augmentation
- had previous replacement of breast implants
- has Baker Class I breast implant capsule
Who cannot join
- has scar capsule contracture around the breast implants of Baker Class II-IV
- is pregnant or may be pregnant
- has possibility or previous history of metallic foreign body
About this study
Official title: Breast Implant Shell Geometry and Edge Scalloping: A Study Using the Upright MRI Machine
The purpose of this study is to determine how different types of breast implants contour to the chest wall.
- Conditions
- Breast Augmentation
- Keywords
- Breast augmentation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2010 (estimated)
- Study startJul 2007
- Primary completionMay 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast AugmentationStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ideal Implant Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01238601
- Sponsor's protocol ID
- Imaging Study of Implants
- Status last verified
- Nov 2010
- First submitted
- 9 Nov 2010
- Last updated
- 11 Nov 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Implant Shell Geometry and Edge Scalloping: A Study Using the Upright MRI Machine
- ClinicalTrials.gov ID
- NCT01238601
- Acronym / sponsor ID
- Imaging Study of Implants
- Conditions
- Breast Augmentation
- Keywords
- Breast augmentation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Ideal Implant IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 10 Nov 2010 (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 purpose of this study is to determine how different types of breast implants contour to the chest wall.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women 20-50 who previously had primary breast augmentation or replacement of existing breast implants.
Key inclusion criteria (3 listed)
- had previous primary breast augmentation
- had previous replacement of breast implants
- has Baker Class I breast implant capsule
Key exclusion criteria (3 listed)
- has scar capsule contracture around the breast implants of Baker Class II-IV
- is pregnant or may be pregnant
- has possibility or previous history of metallic foreign body
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
Not reported in the source record.
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 11 Nov 2010.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Augmentation, run by Ideal Implant Incorporated.
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 3 inclusion and 3 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 11 Nov 2010. 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.
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 11 Nov 2010.