A 7-year Follow up of All Subjects Incuded in Protocol 31GB0106
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 6
- 试验地点
- 4
- 主要终点
- To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Participant in 31GB0601
排除标准
- •There are no exclusion citeria in this study
研究组 & 干预措施
Participants in the Pilot study 31GB0601
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
干预措施: Radiologial breast examination (Radiation)
结局指标
主要结局
To Evaluate if the Subject Has Macrolane Deposits in the Breast Seven Years Post Treatment, Using a Comprehensive MRI Investigation
时间窗: 7 years +/- 6months post treatment
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.
To Evaluate the Long Term Safety of Macrolane in Breast Enhancement
时间窗: 7 years +/- 6 months post treatment
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
次要结局
未报告次要终点