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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

November 9, 2010
November 10, 2010
July 2007
May 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01238601 on ClinicalTrials.gov Archive Site
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Upright Magnetic Resonance Imaging (MRI) Study - Breast Implant Shell Geometry and Edge Scalloping
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.

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Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

Women 20-50 who previously had primary breast augmentation or replacement of existing breast implants.

Breast Augmentation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Female
20 Years to 50 Years
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Contact information is only displayed when the study is recruiting subjects
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NCT01238601
Imaging Study of Implants
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Robert S Hamas, MD, President, Ideal Implant Incorporated
Ideal Implant Incorporated
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Ideal Implant Incorporated
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP