A Post Market Non-Interventional Study of Safety and Performance of RefillHA Volume, a Dermal Filler for Facial Soft Tissue Augmentation and Correction of Facial Wrinkles and Folds.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- 1. The frequency of reported adverse events (number of participants who experienced each reported adverse event). 2. The severity of reported adverse events (1=mild, 2=moderate, 3=severe)
研究概览
简要总结
This study designed to evaluate the safety and performance of RefillHA Volume, a dermal filler for facial soft tissue augmentation and correction of facial wrinkles and folds in routine clinical setting.
详细描述
This post market study was designed to collect clinical data regarding the safety and performance of RefillHA Volume upon its launch, from patients treated with the product in a routine clinical setting of treatments.
In this study, patients seeking correction of facial wrinkles and folds and/or soft tissue augmentation who are candidates for treatment with RefillHA Volume according to its approved use will be offered to participate in the study. Eligible patients who are willing to participate in the study, after signing an informed consent, will be treated with RefillHA Volume in the facial regions where correction is requested, subject to the advice of the treating physician and in accordance with the approved use.
After recieving initial treatment, participants will attend 2 to 4 in-clinic follow-up visits, during which they were eligible to receive additional treatment with RefillHA Volume (up to two additional treatments during the follow-up period) if, per treating investigator's opinion, additional treatment is required for better correction or to maintain the results.
Clinical data were collected at all in clinic visits, including standardized facial photographs, pain perception self-assessement was recorded by subjects immediately after treatment. All subjects were asked for details of any Adverse Events (AEs) they had experienced. Subjects were asked to rate aesthetic results and Patient Satisfaction questionnaire at each follow-up visit. Physicians were asked to rate aesthetic results as well and details of the treatment session were recorded.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult men and women, over the age of 18, seeking correction of facial wrinkles and folds and/or soft tissue augmentation.
- •Subjects who are willing and able to read, understand and sign informed consent.
排除标准
- •Subjects with known contraindications to the treatment (as per device IFU).
- •Subjects considered to be unsuitable to participate, in the investigator's opinion, for any reason.
研究组 & 干预措施
Subjects over the age of 18
Subjects who are seeking correction of facial wrinkles and folds and/or soft tissue augmentation
结局指标
主要结局
1. The frequency of reported adverse events (number of participants who experienced each reported adverse event). 2. The severity of reported adverse events (1=mild, 2=moderate, 3=severe)
时间窗: Up to 56 weeks after treatment
次要结局
未报告次要终点