Clinical trial NCT00684749: A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
Official title: Pilot Study to Investigate The BodyLogic TM System (Mentor) in Breast Augmentation.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Augmentation
Breast Reconstruction
Keywords: Mentor BodyLogic TM System
Breast augmentation
Breast implant choice
Reoperation rates
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Mentor Worldwide, LLC
First posted: 2008-05-28
Enrollment: 142
Sex: FEMALE
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female patients having cosmetic breast augmentation.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Breast reconstruction
* Secondary breast augmentation
* \<22 years of age

Primary outcomes:
measure: Reoperation Rates
timeFrame: 2 years
Secondary outcomes:
measure: Patient Satisfaction With Outcome
timeFrame: 1 Year
measure: Surgeon Satisfaction With Outcome
timeFrame: 1 Year
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Umar H Choudry, MD
role: PRINCIPAL_INVESTIGATOR
References: