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

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ClinicalTrials.gov Identifier: NCT00684749
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Collaborator:
Mentor Worldwide, LLC
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease
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 Design
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Study Type : Observational
Actual Enrollment : 142 participants
Time Perspective: Prospective
Official Title: Pilot Study to Investigate The BodyLogic TM System (Mentor) in Breast Augmentation.
Study Start Date : May 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Reoperation Rates [ Time Frame: 2 years ]
    Surgeon completed survey


Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female patients having cosmetic breast augmentation.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684749


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
Mentor Worldwide, LLC
Investigators
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Principal Investigator: Umar H Choudry, MD University of Minnesota
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT00684749    
Other Study ID Numbers: 0801E25711
First Posted: May 28, 2008    Key Record Dates
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015
Last Verified: February 2015
Keywords provided by University of Minnesota:
Mentor BodyLogic TM System
Breast augmentation
Breast implant choice
Reoperation rates