NCT00684749

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2008

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

February 23, 2015

Completed
Last Updated

February 23, 2015

Status Verified

February 1, 2015

Enrollment Period

2.3 years

First QC Date

May 22, 2008

Results QC Date

February 20, 2013

Last Update Submit

February 19, 2015

Conditions

Breast AugmentationBreast Reconstruction

Keywords

Mentor BodyLogic TM SystemBreast augmentationBreast implant choiceReoperation rates

Outcome Measures

Primary Outcomes (1)

  • Reoperation Rates

    Surgeon completed survey

    2 years

Secondary Outcomes (2)

  • Patient Satisfaction With Outcome

    1 Year

  • Surgeon Satisfaction With Outcome

    1 Year

Eligibility Criteria

Age22 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Female patients having cosmetic breast augmentation.

You may qualify if:

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

You may not qualify if:

  • Breast reconstruction
  • Secondary breast augmentation
  • \<22 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Limitations and Caveats

snap shot view, responder bias

Results Point of Contact

Title
Umar Choudry/Bruce Cunningham
Organization
University of Minnesota
choud008@umn.edu
6126250697

Study Officials

  • Umar H Choudry, MD

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2008

First Posted

May 28, 2008

Study Start

May 1, 2008

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

February 23, 2015

Results First Posted

February 23, 2015

Record last verified: 2015-02

Locations

US(1)