Evaluation of Physician Volumetric Accuracy During Hyaluronic Acid Soft Tissue Filler Injections and the Effect of Products' Biophysical Properties on an Injector's Performance: An Observational, Proof-of-concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Volumetric accuracy of HA filler injections using observational methods
研究概览
简要总结
Objectives
- Evaluate the ability of aesthetic physicians to accurately inject a specific amount (i.e., 0.2cc) of HA soft tissue filler; and
- Investigate the effect of different HA gel properties (e.g., G', cohesivity, viscoelasticity) on an injector's performance accuracy.
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
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Board-certified plastic surgeon, dermatologist, or oculoplastic surgeon.
排除标准
- 未提供
结局指标
主要结局
Volumetric accuracy of HA filler injections using observational methods
时间窗: Baseline
physicians will attempt to inject 0.2CC of four HA products into a porcine membrane. Volumes will be measured in CC's and their accuracy assessed based on the amount of product left in the syringe.
Volumetric accuracy of HA filler expulsions over a scale
时间窗: Baseline
Physicians will attempt to dispense 0.2CC of four different HA products. They will do this into free air, over a scale. The weights will be calculated in grams and converted to CC's. The scale is the "Smart Weight" digital milligram scale, JDS20 edition. It's specifications are as follows: capacity: 20g/100ct/308.8gn/12.86dwt; readability: 0.001g/0.005ct/0.02gn/0.001dwt; scale dimensions: 3x5x0.8"; accuracy of 0.001grams and capacity of 20grams.
次要结局
未报告次要终点