Breast Reconstruction Clinical Trial
Official title:
Pilot Study to Investigate The BodyLogic TM System (Mentor) in Breast Augmentation.
At a national level of 15%, the reoperation rate following augmentation mammaplasty is too high. We are conducting a survey to examine the pre-operative methods by which plastic surgeons determine implant volume, size, shape and location; and to determine if the Mentor "BodyLogic"TM System can successfully improve outcomes. We will evaluate how measurements taken using "BodyLogic"TM influence choice of implant and whether there are any re-operations, particularly for size change. We hypothesize that using this system will help surgeons choose appropriate implants that will decrease the rate of reoperations, especially for size change.
Status | Completed |
Enrollment | 142 |
Est. completion date | December 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 22 Years and older |
Eligibility |
Inclusion Criteria: - Female (age > 22 years) - Cosmetic Breast Augmentation only - Primary breast augmentation Exclusion Criteria: - Breast reconstruction - Secondary breast augmentation - <22 years of age |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute | Mentor Worldwide, LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reoperation Rates | Surgeon completed survey | 2 years | No |
Secondary | Patient Satisfaction With Outcome | Patient completed a survey regarding outcome | 1 Year | No |
Secondary | Surgeon Satisfaction With Outcome | Patient completedsurvey regarding outcome | 1 Year | No |
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