A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty

Completed

• Conditions: Breast Augmentation; Breast Reconstruction

• Registration Number: NCT00684749
• Lead Sponsor: University of Minnesota

Brief 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.

Detailed Description

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:

1. Complete a 'general preference questionnaire', designed to document current preoperative planning and assessment methods for breast augmentation.

2. 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.

3. 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.

4. 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.

5. 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 Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-22
• Study First Submitted QC: 2008-05-27
• Study First Posted: 2008-05-28
• Primary Completion: 2010-09
• Study Completion: 2010-12
• Results First Submitted: 2013-02-20
• Status Verified: 2015-02
• Results First Submitted QC: 2015-02-19
• Last Update Submitted: 2015-02-19
• Results First Posted: 2015-02-23
• Last Update Posted: 2015-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 142

Inclusion Criteria

• Female (age > 22 years)
• Cosmetic Breast Augmentation only
• Primary breast augmentation

Exclusion Criteria

• Breast reconstruction
• Secondary breast augmentation
• <22 years of age

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reoperation Rates	2 years	Surgeon completed survey

Secondary Outcome Measures

Name	Time	Method
Surgeon Satisfaction With Outcome	1 Year	Patient completedsurvey regarding outcome
Patient Satisfaction With Outcome	1 Year	Patient completed a survey regarding outcome

Trial Locations

Locations (1)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States