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Completed

NCT Number: NCT00684749

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

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.

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Key information

Conditions

Breast Augmentation Breast Reconstruction

Age range

22 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Reoperation Rates

    Time frame: 2 years

    Surgeon completed survey

Secondary outcomes

  1. Patient Satisfaction With Outcome

    Time frame: 1 Year

    Patient completed a survey regarding outcome

  2. Surgeon Satisfaction With Outcome

    Time frame: 1 Year

    Patient completedsurvey regarding outcome

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Mentor Worldwide, LLC

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 28, 2008
Registry last updated
Feb 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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