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
  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

Ages Eligible for Study:   20 Years to 50 Years
Genders 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

No publications provided

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
Study First Received: November 9, 2010
Last Updated: November 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Ideal Implant Incorporated:
Breast augmentation

ClinicalTrials.gov processed this record on April 15, 2014