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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00684749
Other study ID # 0801E25711
Secondary ID
Status Completed
Phase N/A
First received May 22, 2008
Last updated February 19, 2015
Start date May 2008
Est. completion date December 2010

Study information

Verified date February 2015
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 142
Est. completion date December 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Female
Age group 22 Years and older
Eligibility Inclusion Criteria:

- Female (age > 22 years)

- Cosmetic Breast Augmentation only

- Primary breast augmentation

Exclusion Criteria:

- Breast reconstruction

- Secondary breast augmentation

- <22 years of age

Study Design

Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (2)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute Mentor Worldwide, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reoperation Rates Surgeon completed survey 2 years No
Secondary Patient Satisfaction With Outcome Patient completed a survey regarding outcome 1 Year No
Secondary Surgeon Satisfaction With Outcome Patient completedsurvey regarding outcome 1 Year No
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