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
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, see Learn About Clinical Studies.

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 September 18, 2014