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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P060028 / PAS005 |
| Date Original Protocol Accepted |
06/14/2013
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| Date Current Protocol Accepted |
06/14/2013
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| Study Name |
Focus Group Study
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| Device Name |
MENTOR MEMORYSHAPE BREAST IMPLANTS
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| General Study Protocol Parameters |
| Study Design |
Other Study Design
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of the Focus Group Study is to evaluate the patient informed decision brochure and ensure that the consumer information for Memory Shape Breast Implant meets patients and FDA¿s requirements.
The focus group will be conducted in person, rather than on the telephone with a moderator in the room.
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| Study Population |
Women who have had breast reconstruction or breast augmentation or currently considering breast implant revision. At least 20% of participants should be non-Caucasian. For augmentation groups, at least 50% of participants must be between ages 25 to 35 years old.
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| Sample Size |
Five in-person focus groups will be conducted (minimum eight respondents per conference): Augmentation
¿1 conference with women who have had breast augmentation
¿1 conference with women who have considered or are considering breast augmentation
Reconstruction
¿1 conference with women who have had breast reconstruction
¿1 conference with women who have considered or are considering breast reconstruction
Revision
¿1 conference with women who currently have breast implants and are considering or may have considered revision surgery to replace one or both of their implants
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| Key Study Endpoints |
The study will employ two methods of data collection, focus groups and a self-administered survey, to capture both group-level and individual-level data.
A moderator will lead each group using discussion guide. Throughout the discussion, the moderator will pay attention to any unintended effects of the materials¿ content, particularly if respondents have any perceptions or beliefs that are inconsistent with the facts included in the patient educational material. Additionally, the moderator will probe for reactions to the sequencing of information, layout and format, and the effectiveness and clarity of data displays and other visual aids.
Respondents will also complete a self-administered survey designed to yield individual-level data on a number of critical questions. The survey will be designed to measure how well respondents¿ comprehended key information from the patient educational material, specifically what was learned in terms of the risks and benefits of receiving breast implants.
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| Follow-up Visits and Length of Follow-up |
There is no follow-up in the Focus Group Study
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
33 (18 in the augmentation group and 15 in the reconstruction group)
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| Actual Number of Sites Enrolled |
7
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| Patient Follow-up Rate |
N/A
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| Final Safety Findings |
Overall reactions to the patient educational materials are generally positive. Respondents in both the augmentation and reconstruction groups agree that the Patient Educational Brochure is relevant and clear. The study participants also offered suggestions for improving the materials.
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| Study Strengths & Weaknesses |
The focus group study is quick, usually inexpensive, and useful in exploring ideas and concepts through group interaction. However, the analysis is qualitative, it is difficult to generalize results if small, unrepresentative samples of participants are used, and data analysis can be time consuming due to the open]ended nature of questions proposed for the focus group discussion.
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| Recommendations for Labeling Changes |
No labeling change is recommended. The Focus Group Study was conducted to evaluate Patient Educational Brochures. No safety/effectiveness data of the sponsorfs approved device was collected in the study.
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