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

NCT01238601 | Completed

• 1 other identifier: Imaging Study of Implants
• Study Type: observational
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Breast Augmentation

Keywords

Breast augmentation

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women 20-50 who previously had primary breast augmentation or replacement of existing breast implants.

You may qualify if:

• had previous primary breast augmentation
• had previous replacement of breast implants
• has Baker Class I breast implant capsule

You may not qualify if:

• 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

Sponsors & Collaborators

• Ideal Implant Incorporated: lead

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 9, 2010
• First Posted: November 10, 2010
• Study Start: July 1, 2007
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: November 11, 2010

Record last verified: 2010-11