A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
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|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|
|Actual Primary Completion Date :||September 2010|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|