NCT06322043进行中（未招募）不适用
A Single-Arm Pilot Study to Evaluate the Safety of Adipearl Injection in the Subcutaneous Tissues of Adults
Volumina Medical S.A.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2024年3月26日最近更新:
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Safety of Investigational Medical Device
研究概览
简要总结
Adipearl is an injectable filler intended to be injected subcutaneously.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject having given freely and expressly informed consent;
- •Subject deemed by the Investigator to be medically fit for injection of the product;
- •Female or male subjects aged 22 to 65 years (inclusive);
排除标准
- •Pregnant or nursing woman or planning a pregnancy during the study.
- •Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- •Subject participating to another research study.
- •Subject with the presence of any condition, which in the opinion of the Principal Investigator, that makes her/him unable to complete the study per protocol.
研究组 & 干预措施
Volume correction with Investigational Device
Experimental
Subjects will be injected subcutaneously with the Investigational Device to correct volume deficiencies.
干预措施: Adipearl (Device)
结局指标
主要结局
Safety of Investigational Medical Device
时间窗: 6-Months
Collection of Injection Site Reactions and Adverse Events during the study.
次要结局
未报告次要终点
研究者
研究点 (1)
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