A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106

Study Overview
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Brief Summary
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Several subjects included in a Pilot study (CTN 31GB0106) during 2002-2003 still had Macrolane deposits in the breast when the last study visit was performed. An additional follow up visit is planned to follow duration and safety of the former formulation of Macrolane that was used in the Pilot study (CTN 31GB0106).

Detailed Description
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All subjects included in a Pilot study between 2002-2003 (CTN 31GB0106) are offered to take part in a seven year safety follow up after the initial injection of the former formulation of Macrolane into the breasts. The study will not involve any additional treatments. The follow up will include relevant medical history, weight, breast examination, ultrasound and mammography to determine if there are/have been any safety issues since the final study visit in the Pilot study (CTN 31GB0106), as well as a comprehensive MRI investigation to assess the breast structure and determine if there are still deposits of Macrolane in the breast.

Official Title
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A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106

Conditions
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Breast Augmentation

Intervention / Treatment
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* Radiation: Radiologial breast examination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant in 31GB0601 Exclusion Criteria: There are no exclusion citeria in this study
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Participants in the Pilot study 31GB0601<br>This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane for breast augmentation. Radiological breast examinations - MRI of breast, mammography and ultrasound of breast | Radiation: Radiologial breast examination<br>* MRI of breast, mammography and ultrasound of breast<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation | The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment. | 7 years +/- 6months post treatment | 
| To Evaluate the Long Term Safety of Macrolane in Breast Enhancement | To evaluate the long term safety of Macrolane in breast enhancement, using relevant medical history, breast examination, mammography and ultrasound as well as a comprehensive MRI investigation. Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation | 7 years +/- 6 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patients who participated in pilot study (31GB0601) and performed breast augmentation with previous formulation of Macrolane