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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: November 10, 2010
Last Update Posted: November 11, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Ideal Implant Incorporated
The purpose of this study is to determine how different types of breast implants contour to the chest wall.

Breast Augmentation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Breast Implant Shell Geometry and Edge Scalloping: A Study Using the Upright MRI Machine

Resource links provided by NLM:

Further study details as provided by Ideal Implant Incorporated:

Enrollment: 18
Study Start Date: July 2007
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)

Information from the National Library of Medicine

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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.

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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 Submitted: November 9, 2010
First Posted: November 10, 2010
Last Update Posted: November 11, 2010
Last Verified: November 2010

Keywords provided by Ideal Implant Incorporated:
Breast augmentation