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
Results First Received: February 20, 2013  
Study Type: Observational
Study Design: Time Perspective: Prospective
Conditions: Breast Augmentation
Breast Reconstruction

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Surgeons recruited their own patients in their own offices

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
as above.

Reporting Groups
  Description
Total Population All surgical patients

Participant Flow:   Overall Study
    Total Population  
STARTED     142  
COMPLETED     142  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Total Population All surgical patients

Baseline Measures
    Total Population  
Number of Participants  
[units: participants]
  142  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     142  
>=65 years     0  
Gender  
[units: participants]
 
Female     142  
Male     0  



  Outcome Measures

1.  Primary:   Reoperation Rates   [ Time Frame: 2 years ]

2.  Secondary:   Patient Satisfaction With Outcome   [ Time Frame: 1 Year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Surgeon Satisfaction With Outcome   [ Time Frame: 1 Year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
snap shot view, responder bias


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Umar Choudry/Bruce Cunningham
Organization: University of Minnesota
phone: 6126250697
e-mail: choud008@umn.edu


No publications provided


Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00684749     History of Changes
Other Study ID Numbers: 0801E25711
Study First Received: May 22, 2008
Results First Received: February 20, 2013
Last Updated: February 19, 2015
Health Authority: United States: Institutional Review Board