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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by University of Minnesota - Clinical and Translational Science Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Mentor Worldwide, LLC
Information provided by:
University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier:
NCT00684749
First received: May 22, 2008
Last updated: March 5, 2010
Last verified: March 2010
  Purpose

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
Breast Augmentation
Breast Reconstruction

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Pilot Study to Investigate The BodyLogic TM System (Mentor) in Breast Augmentation.

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute:

Primary Outcome Measures:
  • Reoperation rates [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: May 2008
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   22 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Female patients having cosmetic breast augmentation.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684749

Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Mentor Worldwide, LLC
Investigators
Principal Investigator: Umar H Choudry, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

No publications provided

Responsible Party: Umar Choudry, MD, University of Minnesota
ClinicalTrials.gov Identifier: NCT00684749     History of Changes
Other Study ID Numbers: 0801E25711
Study First Received: May 22, 2008
Last Updated: March 5, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Mentor BodyLogic TM System
Breast augmentation
Breast implant choice
Reoperation rates

ClinicalTrials.gov processed this record on July 24, 2014