NCT05016674撤回不适用
Assessment of Cellular and Tissue Characteristics in Lipoaspirates Harvested With the LipoLife System and Stirred by VorFat
Alma Lasers2 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2021年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Average adipose cell cluster size
研究概览
简要总结
Single-center, prospective, open-label study. The study aims to assess the structure and viability of fat collected during the LipoLife liposuction procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects scheduled to undergo abdominal w/wo flanks laser-assisted liposuction surgery and are willing to donate the harvested adipose tissue for the study assessment.
- •Between 18 and 70 years of age.
- •Estimated fat harvesting of at least 300 milliliters.
- •Provided written Informed Consent.
排除标准
- •Pregnant or intending to become pregnant during the course of study.
- •Current smoker.
- •Presence of known malignancy.
- •Active infection in the treatment area.
- •History of autoimmune disorder (e.g., Systemic Lupus Erythematosus [SLE]).
- •History of connective, metabolic, or atrophic skin disease.
- •History of keloid scarring.
- •Chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs within 15 days before enrollment.
- •Subjects with immune system diseases.
- •Any other reason that in the opinion of the investigator, prevents the subject from participating in the study or compromises the subject safety.
结局指标
主要结局
Average adipose cell cluster size
时间窗: 6 months
Assessment of adipose cell cluster size by microscope
次要结局
未报告次要终点
研究者
研究点 (2)
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