N/A
Completed N=142
A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
Breast Augmentation · Breast Reconstruction
Source: ClinicalTrials.gov NCT00684749 ↗
Enrolled (actual)
142
Serious AEs
0.0%
Results posted
Feb 2015
Primary outcomePrimary: Reoperation Rates — 6 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reoperation Rates |
6 | — |
| SECONDARY Patient Satisfaction With Outcome |
— | — |
| SECONDARY Surgeon Satisfaction With Outcome |
— | — |
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. Informational only — not medical advice.