NCT06089759已完成不适用
Performance and Safety of the Lipo-transfer Cannulas in Patients Underlying Lipofilling Treatment
Aesthetic Group3 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2023年8月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 3
- 主要终点
- The performance of the cannulas for infiltration, fat harvesting or fat injection.
研究概览
简要总结
The purpose of this post-market clinical follow up study is to assess the safety and performance of Aesthetic Group cannulas. The study will evaluate the outcome of the Aesthetic Group cannulas range over a period of 1 month after intervention.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- 否
入选标准
- •Patient age ≥ 18 years at intervention
- •Patient who will undergo a lipofilling treatment with at least one cannula of Aesthetic Group
- •Patient informed of his/her participation and willing to participate in the study.
- •Patient able to read, write and understand French.
排除标准
- •Patient deprived of freedom, under guardianship/curatorship or placed under judicial protection
- •Patient unable to follow study procedures
- •Patient with hematologic abnormalities, prior radiotherapy or chemotherapy
- •Chronic use of medicines or drugs
- •Patient with diabetes mellitus
- •Patient with connective tissue diseases, any type of fat tissue disorder (lipodystrophy)
- •Patient with bleeding disorders; immune deficits; heart, liver, and kidney insufficiency
- •Patient with allergies to local anaesthetics
- •Patient with pacemaker and serious heart rhythm disorders
- •Pregnant and breastfeeding women
结局指标
主要结局
The performance of the cannulas for infiltration, fat harvesting or fat injection.
时间窗: D0 (at intervention)
The success rate of cannulas defined by the capacity to infiltrate, harvest or inject.
次要结局
- The safety of the cannulas during the intervention (All adverse device effects occurred during the intervention will be summarized)(D0 (at intervention))
- The quality of life(At baseline and 1 month follow-up)
- The safety of the intervention within the 1 month post intervention (All adverse events occurred from the intervention to the 1 month follow-up visit will be summarized)(D0 (at intervention) to month 1)
- The usability of the cannulas during the intervention(D0 (at intervention))
- The surgeon's satisfaction with the procedure(D0 (at intervention))
- The improvement of skin quality/aesthetic (likert scale)(At 1 month)
- The patient's satisfaction at 1 month (binary variable)(At 1 month)
- The surgeon's satisfaction at 1 month(At 1 month)
研究者
研究点 (3)
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