N/A
N=142
A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
Breast Augmentation · Breast Reconstruction
Bottom Line
View on ClinicalTrials.gov: NCT00684749 ↗Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcome: Primary: Reoperation Rates — 6 participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- Female
- Sponsor
- University of Minnesota
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reoperation Rates |
6 | — |
| SECONDARY Patient Satisfaction With Outcome |
— | — |
| SECONDARY Surgeon Satisfaction With Outcome |
— | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Female (age > 22 years)
- Cosmetic Breast Augmentation only
- Primary breast augmentation
Exclusion Criteria
- Breast reconstruction
- Secondary breast augmentation
- <22 years of age
Data sourced from ClinicalTrials.gov (NCT00684749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.