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NCT01238601 Clinical Trial

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

Breast Augmentation Clinical Trial

Official title:
Breast Implant Shell Geometry and Edge Scalloping: A Study Using the Upright MRI Machine

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01238601
Other study ID # Imaging Study of Implants
Secondary ID
Status Completed
Phase N/A
First received November 9, 2010
Last updated November 10, 2010
Start date July 2007
Est. completion date May 2010

Study information
Verified date November 2010
Source Ideal Implant Incorporated
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date May 2010
Est. primary completion date May 2010
Accepts healthy volunteers
Gender Female
Age group 20 Years to 50 Years
Eligibility 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

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ideal Implant Incorporated
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