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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01238601
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
  Purpose
The purpose of this study is to determine how different types of breast implants contour to the chest wall.

Condition
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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  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