Macrolane VRF30 for Enhancement of Shape and Fullness of Female Breast

Study Overview
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Brief Summary
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This is an open, multi-center, non comparative study to evaluate the safety and efficacy of Macrolane VRF30 in the female breast. 71 subjects have received initial treatment with a maximum of 120 ml of Macrolane VRF30 per breast. 22 patients have received a re-injection (max 120 ml/breast) of Macrolane nine months after initial treatment. Patients are followed for 24 months after last treatment.

Official Title
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An Open, Multi-center Study Evaluating Efficacy and Safety of Macrolane VRF30 for Enhancement of the Shape and Fullness of the Female Breast

Conditions
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Breast Enhancement

Intervention / Treatment
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* Device: Macrolane VRF30


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients between 25 and 60 years with small breasts seeking enhancement of the shape and fullness of the breast Exclusion Criteria: Unreasonable expectations as regards the increase in breast volume Any medical conditions that may interfere in any way.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Macrolane VRF30<br> | Device: Macrolane VRF30<br>* Device: Macrolane VRF30 (stabilized hyaluronic acid of non-animal origin) Treatment: Initial injection of a maximum of 120 ml/breast. Re-injection of a maximum of 120 ml/breast in a subgroup of subjects.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived improvement of shape and fullness of the female breast compared to baseline as judged by the subject using GEIS. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety as documented by physical examination, mammography, ultrasonography and by adverse events reported. |  | 24 months | 
| To evaluate adverse experiences occurring during the first 2 weeks post treatment as recorded in the diary. |  | 2 weeks | 
| to study the implant duration and localization as documented by MRI. |  | 24 months | 
| to evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS. |  | 24 months | 
| to evaluate the subjects satisfaction with her breast and general appearance using a subject questionnaire. |  | 24 months | 
| to evaluate pain experience during injection under local anesthesia. |  | during injection | 
| To evaluate any difficulties with the interpretation of the mammography image(s)or ultrasonography due to the presence of the implant 24 months after the initial treatment |  | 24 months | 
| Re-treatment phase: To evaluate the safety documented by physical examination and by adverse events reported up to 24 months after re-treatment and by mammography and ultrasonography examinations 15 and 39 months after re-treatment. |  | 39 months | 
| Re-treatment phase: To evaluate any difficulties with the interpretation of the mammography image(s) or ultrasonography due to the presence of the implant 24 and 48 months after the initial treatment (15 and 39 months after the re-treatment). |  | 48 months | 
| Re-treatment phase: To evaluate adverse experiences occurring during the first 2 weeks post re-treatment as recorded in the diary. |  | 2 weeks | 
| Re-treatment phase: To study the implant duration and localization as documented by MRI up to 24 months after re-treatment. |  | 24 months | 
| Re-treatment phase: To evaluate esthetic improvement of shape and fullness as judged by an independent evaluator, by the investigator and by the subject using GEIS up to 24 months after re-treatment. |  | 24 months | 
| Re-treatment phase: To evaluate, up to 24 months after re-treatment, the subjects satisfaction with her breast and general appearance using a subject questionnaire. |  | 24 months | 
| Re-treatment phase: To evaluate pain experience during re-injection under local anaesthesia. |  | During re-injection | 
| Re-treatment phase: To evaluate if there are differences in esthetic improvement, subject satisfaction and implant duration, after re-treatment compared to after initial treatment. The visits up to 9 months will be compared. |  | 9 months | 
| Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 24 months after last treatment between subjects that have received only one treatment and subjects that have received re-treatment. |  | 24 months | 
| Re-treatment phase: To compare esthetic improvement, subject satisfaction and implant duration at 12 and 24 months after initial treatment between subjects that have received only one treatment and subjects that have received re-treatment. |  | 24 months |