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

Breast Reconstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684749
• Other study ID #: 0801E25711
• Status: Completed
• Phase: N/A
• First received: May 22, 2008
• Last updated: February 19, 2015
• Start date: May 2008
• Est. completion date: December 2010

Study information

• Verified date: February 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: December 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Augmentation
• Breast Reconstruction

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	Mentor Worldwide, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reoperation Rates	Surgeon completed survey	2 years	No
Secondary	Patient Satisfaction With Outcome	Patient completed a survey regarding outcome	1 Year	No
Secondary	Surgeon Satisfaction With Outcome	Patient completedsurvey regarding outcome	1 Year	No