Overview

This trial is active, not recruiting.

Conditions breast augmentation, breast reconstruction
Sponsor University of Minnesota - Clinical and Translational Science Institute
Collaborator Mentor Worldwide, LLC
Start date May 2008
End date September 2010
Trial size 300 participants
Trial identifier NCT00684749, 0801E25711

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective

Primary Outcomes

Measure
Reoperation rates
time frame: 1 year

Secondary Outcomes

Measure
Patient satisfaction with outcome
time frame: 1 Year
Surgeon Satisfaction with outcome
time frame: 1 Year

Eligibility Criteria

Female participants at least 22 years old.

Inclusion Criteria: - Plastic surgeons who do breast augmentations - Female (age > 22 years) - Cosmetic Breast Augmentation only - Primary breast augmentation Exclusion Criteria: - Breast reconstruction - Secondary breast augmentation - <22 years of age

Additional Information

Official title Pilot Study to Investigate The BodyLogic TM System (Mentor) in Breast Augmentation.
Principal investigator Umar H Choudry, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by University of Minnesota - Clinical and Translational Science Institute.