Upright Magnetic Resonance Imaging (MRI) Study - Breast Implant Shell Geometry and Edge Scalloping

This study has been completed.

Sponsor:

Information provided by:

Ideal Implant Incorporated

ClinicalTrials.gov Identifier:

NCT01238601

First received: November 9, 2010

Last updated: November 10, 2010

Last verified: November 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	November 9, 2010
Last Updated Date	November 10, 2010
Start Date ^ICMJE	July 2007
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT01238601 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Upright Magnetic Resonance Imaging (MRI) Study - Breast Implant Shell Geometry and Edge Scalloping
Official Title ^ICMJE	Breast Implant Shell Geometry and Edge Scalloping: A Study Using the Upright MRI Machine
Brief Summary	The purpose of this study is to determine how different types of breast implants contour to the chest wall.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Cross-Sectional
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Women 20-50 who previously had primary breast augmentation or replacement of existing breast implants.
Condition ^ICMJE	Breast Augmentation
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	18
Completion Date	May 2010
Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: had previous primary breast augmentation had previous replacement of breast implants has Baker Class I breast implant capsule Exclusion Criteria: 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
Gender	Female
Ages	20 Years to 50 Years
Accepts Healthy Volunteers	Not Provided
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01238601
Other Study ID Numbers ^ICMJE	Imaging Study of Implants
Has Data Monitoring Committee	Not Provided
Responsible Party	Robert S Hamas, MD, President, Ideal Implant Incorporated
Study Sponsor ^ICMJE	Ideal Implant Incorporated
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Ideal Implant Incorporated
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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