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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00684749
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Information provided by (Responsible Party):

Study Type: Observational
Study Design: Time Perspective: Prospective
Conditions: Breast Augmentation
Breast Reconstruction

  Participant Flow

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
Total Population All surgical patients

Participant Flow:   Overall Study
    Total Population
STARTED   142 

  Baseline Characteristics

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
Total Population All surgical patients

Baseline Measures
   Total Population 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   142 
>=65 years   0 
[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.  

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

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

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

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

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00684749     History of Changes
Other Study ID Numbers: 0801E25711
First Submitted: May 22, 2008
First Posted: May 28, 2008
Results First Submitted: February 20, 2013
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015