A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
|ClinicalTrials.gov Identifier: NCT00684749|
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
|Condition or disease|
|Breast Augmentation Breast Reconstruction|
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.
|Study Type :||Observational|
|Actual Enrollment :||142 participants|
|Official Title:||Pilot Study to Investigate The BodyLogic TM System (Mentor) in Breast Augmentation.|
|Study Start Date :||May 2008|
|Primary Completion Date :||September 2010|
|Study Completion Date :||December 2010|
- Reoperation Rates [ Time Frame: 2 years ]Surgeon completed survey
- Patient Satisfaction With Outcome [ Time Frame: 1 Year ]Patient completed a survey regarding outcome
- Surgeon Satisfaction With Outcome [ Time Frame: 1 Year ]Patient completedsurvey regarding outcome
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|