NCT02348931Unknown3 期
Investigation of the Effect of a Customized Nasal Brace on Nasal Deformities With or Without Prior Surgery
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Broad nose: Appealing proportion of nose width to eye-corner distance.
研究概览
简要总结
Investigation of the effect of customized nasal braces in the correction of nasal deformities with and without prior corrective surgery.
- Trial with medicinal product
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Broad nose: Appealing proportion of nose width to eye-corner distance.
时间窗: 14 months of treatment with Nasella
The improvement of proportion of width compare to study start
Skewed nose: Deviation from the 0° axis in the coronar plain (Philtrum-Glabella line).
时间窗: 14 months of treatment with Nasella
The improvement in degrees compared to study start
Humped nose: Deviation from the 0° axis in the sagittal plain (line from nose root to tip).
时间窗: 14 months of treatment with Nasella
The improvement in degrees compared to study start
次要结局
- Doctors assessment of various appearances(14 months after treatment)
- Subjective Satisfaction(14 months of treatment)
研究者
研究点 (2)
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