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

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ClinicalTrials.gov Identifier: NCT01238601
Recruitment Status : Completed
First Posted : November 10, 2010
Last Update Posted : November 11, 2010
Sponsor:
Information provided by:
Ideal Implant Incorporated

Brief Summary:
The purpose of this study is to determine how different types of breast implants contour to the chest wall.

Condition or disease
Breast Augmentation

Study Type : Observational
Actual Enrollment : 18 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Breast Implant Shell Geometry and Edge Scalloping: A Study Using the Upright MRI Machine
Study Start Date : July 2007
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Sampling Method:   Non-Probability Sample
Study Population
Women 20-50 who previously had primary breast augmentation or replacement of existing breast implants.
Criteria

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

Responsible Party: Robert S Hamas, MD, President, Ideal Implant Incorporated
ClinicalTrials.gov Identifier: NCT01238601     History of Changes
Other Study ID Numbers: Imaging Study of Implants
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: November 11, 2010
Last Verified: November 2010

Keywords provided by Ideal Implant Incorporated:
Breast augmentation