A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
Completed
Conditions studied: Breast Augmentation, Breast Reconstruction
In brief
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.
Key facts
- Study ID
- NCT00684749
- Run by
- University of Minnesota
- People needed
- 142
- Starts
- 2008-05-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2015-02-23
Who can join
Age: 22 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Female (age > 22 years)
- Cosmetic Breast Augmentation only
- Primary breast augmentation
You may not qualify if…
- Breast reconstruction
- Secondary breast augmentation
- <22 years of age
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States
Full record on ClinicalTrials.gov
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