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

Pilot Study to Investigate The BodyLogic TM System (Mentor) in Breast Augmentation.

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 Overview

• Status: Completed
• Conditions: Breast Augmentation; Breast Reconstruction

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 Type: Observational
• Enrollment (Actual): 142

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Female patients having cosmetic breast augmentation.

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reoperation Rates	Surgeon completed survey	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction With Outcome	Patient completed a survey regarding outcome	1 Year
Surgeon Satisfaction With Outcome	Patient completedsurvey regarding outcome	1 Year

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: Mentor Worldwide, LLC
• Investigators: Principal Investigator: Umar H Choudry, MD, University of Minnesota

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): September 1, 2010
• Study Completion (Actual): December 1, 2010

Study Registration Dates

• First Submitted: May 22, 2008
• First Submitted That Met QC Criteria: May 27, 2008
• First Posted (Estimate): May 28, 2008

Study Record Updates

• Last Update Posted (Estimate): February 23, 2015
• Last Update Submitted That Met QC Criteria: February 19, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Breast augmentation; Mentor BodyLogic TM System; Breast implant choice; Reoperation rates
• Other Study ID Numbers: 0801E25711