A Pilot Study to Evaluate the BodyLogic TM System (Mentor) in Augmentation Mammaplasty
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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:
-
Complete a 'general preference questionnaire', designed to document current preoperative planning and assessment methods for breast augmentation.
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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.
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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.
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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.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Reoperation Rates [2 years]
Surgeon completed survey
Secondary Outcome Measures
- Patient Satisfaction With Outcome [1 Year]
Patient completed a survey regarding outcome
- Surgeon Satisfaction With Outcome [1 Year]
Patient completedsurvey regarding outcome
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Female (age > 22 years)
-
Cosmetic Breast Augmentation only
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Primary breast augmentation
Exclusion Criteria:
-
Breast reconstruction
-
Secondary breast augmentation
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<22 years of age
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Minnesota | Minneapolis | Minnesota | United States | 55455 |
Sponsors and Collaborators
- University of Minnesota
- Mentor Worldwide, LLC
Investigators
- Principal Investigator: Umar H Choudry, MD, University of Minnesota
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0801E25711
Study Results
Participant Flow
| Recruitment Details | Surgeons recruited their own patients in their own offices |
|---|---|
| Pre-assignment Detail | as above. |
| Arm/Group Title | Total Population |
|---|---|
| Arm/Group Description | All surgical patients |
| Period Title: Overall Study | |
| STARTED | 142 |
| COMPLETED | 142 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Total Population |
|---|---|
| Arm/Group Description | All surgical patients |
| Overall Participants | 142 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
142
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
142
100%
|
| Male |
0
0%
|
Outcome Measures
| Title | Reoperation Rates |
|---|---|
| Description | Surgeon completed survey |
| Time Frame | 2 years |
Outcome Measure Data
| Analysis Population Description |
|---|
| All patients who were treated in the time period |
| Arm/Group Title | Total Population |
|---|---|
| Arm/Group Description | All surgical patients |
| Measure Participants | 142 |
| Number [participants] |
6
4.2%
|
| Title | Patient Satisfaction With Outcome |
|---|---|
| Description | Patient completed a survey regarding outcome |
| Time Frame | 1 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
| Title | Surgeon Satisfaction With Outcome |
|---|---|
| Description | Patient completedsurvey regarding outcome |
| Time Frame | 1 Year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title |
|---|
| Arm/Group Description |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Total Population | |
| Arm/Group Description | All surgical patients | |
All Cause Mortality |
||
| Total Population | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| Total Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/142 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Total Population | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/142 (0%) | |
Limitations/Caveats
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 |
| choud008@umn.edu |
- 0801E25711