European New Texture Implant Clinical Experience With Shaped Breast Implants
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Study Details
Medical Condition
Study Phase
Intervention Type
Date
Participation Requirements
Gender
Age
Healthy Volunteers
Inclusion Criteria
Exclusion Criteria
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Call us @: 844 663-3742
| Location | Status | Site Contact Details |
|---|---|---|
Location Klinik 34, Göteburg, 41124 | Status Not Available | |
Location Akademikliniken 10, Stockholm, 11542 | Status Not Available |
The purpose of this study is to obtain clinical experience with the use of new texture, shaped breast implants in bilateral primary breast augmentation.
Investigator Overall Satisfaction With the Device Using a 5-Point Scale
Time Frame: 3 months
Subject Satisfaction With Breasts Using the BREAST-Q Questionnaire
Time Frame: 6 months
Investigator Evaluation of Whether the Implant is Palpably Distinguishable From the Tissue
Time Frame: 6 months
Percentage of Participants With Capsular Contracture Evaluated by Four-Grade Baker Scale
Time Frame: Interim analysis: 12 months
Percentage of Participants With Local Complications
Time Frame: Interim analysis: 12 months
Interventions:
- Device: new texture shaped breast implants
Enrollment:
19
Additional Information
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