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

This study has been completed.
Sponsor:
Collaborator:
Mentor Worldwide, LLC
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00684749
First received: May 22, 2008
Last updated: February 19, 2015
Last verified: February 2015

May 22, 2008
February 19, 2015
May 2008
September 2010   (final data collection date for primary outcome measure)
Reoperation Rates [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Surgeon completed survey
Reoperation rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00684749 on ClinicalTrials.gov Archive Site
  • Patient Satisfaction With Outcome [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Patient completed a survey regarding outcome
  • Surgeon Satisfaction With Outcome [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Patient completedsurvey regarding outcome
  • Patient satisfaction with outcome [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
  • Surgeon Satisfaction with outcome [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
Pilot Study to Investigate The BodyLogic TM System (Mentor) in Breast Augmentation.

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.

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.
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Female patients having cosmetic breast augmentation.

  • Breast Augmentation
  • Breast Reconstruction
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
December 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Breast reconstruction
  • Secondary breast augmentation
  • <22 years of age
Female
22 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00684749
0801E25711
No
University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
Mentor Worldwide, LLC
Principal Investigator: Umar H Choudry, MD University of Minnesota - Clinical and Translational Science Institute
University of Minnesota - Clinical and Translational Science Institute
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP