A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
Recruitment status was Active, not recruiting
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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Pilot Study to Investigate The BodyLogic TM System (Mentor) in Breast Augmentation.|
- Reoperation rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Patient satisfaction with outcome [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
- Surgeon Satisfaction with outcome [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
|Study Start Date:||May 2008|
|Estimated Study Completion Date:||December 2010|
|Estimated Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
We are planning to survey 10 high volume plastic surgeons that perform at least 10 breast augmentations a month and to collect data on at least 300 patients. The enrollment period will be 3 months.
As part of this study, we are having the following steps performed:
- Complete a 'general preference questionnaire', designed to document current preoperative planning and assessment methods for breast augmentation.
- For each study patient, a pre-operative "BodyLogic"TM worksheet will be completed. Then, using the provided Implant Selection Booklet, the actual implant will be selected. The surgeon will maintain a key of the patients, and will identify them to the investigators only by subject number, and return these forms in provided stamped, self-addressed envelopes.
- The patient returns at 1-3 months and 8-12 months for completion of the respective "Body-Logic" post-operative worksheets for each visit and the surgeon will send us the data in the provided envelopes periodically.
- If during the course of the data collection, the surgeon has to re-operate on any patient, he/she will fill the "re-operative form" and send it to us.
- Finally, the surgeon will complete a post-study evaluation questionnaire to help us understand how the "BodyLogic"TM System worked for him/her and how it could be improved.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684749
|United States, Minnesota|
|University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Umar H Choudry, MD||University of Minnesota - Clinical and Translational Science Institute|