NCT03194269已完成4 期
FOLD: Long Term Prospective Uncontrolled Study Of Earfold™ For The Treatment Of Prominent Ears
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 84
- 试验地点
- 12
- 主要终点
- Change from baseline pre-insertion in EAR-Q Ears Appearance Questionnaire score
研究概览
简要总结
This is an open-label, prospective, uncontrolled, single arm, post-marketing study of the long-term safety and performance of EARFOLD® Implantable Clip System.
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
- 7 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who have ear prominence and/or have significant asymmetry
排除标准
- •Subjects planning to use EARFOLD® in conjunction with other procedures (e.g. cartilage scoring, conchal reduction or concho-mastoid sutures) for correction of prominent ears are excluded
- •Patients with impaired healing (e.g., current smokers, diabetic patients, patients with autoimmune disorders such as Ehlers-Danlos Syndrome or Scleroderma)
- •Patients with an active infection, local or systemic
- •Patients with known nickel or gold allergies.
结局指标
主要结局
Change from baseline pre-insertion in EAR-Q Ears Appearance Questionnaire score
时间窗: Baseline to month 3
EAR-Q Ears Appearance Questionnaire is on a 4 point scale (1=Not at all, 2=A little bit, 3=Quite a bit, 4=Very much)
次要结局
- Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 24 months post-implantation(Baseline to Month 24)
- Change from baseline of Short Form-10 score at Month 24 for subjects under 18 years old(Baseline to Month 24)
- Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 12(Baseline to Month 12)
- Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 3(Baseline to Month 3)
- Change from baseline pre-insertion in EAR-Q Ears Appearance overall score at 12 months post-implantation(Baseline to Month 12)
- Percentage of patients that require re-operation at any moment(24 months)
- Change from baseline of Short Form-12 score at Month 24 for subjects over 18 years(Baseline to Month 24)
- Change from baseline of Short Form-12 score at Month 12 for subjects over 18 years(Baseline to Month 12)
- Change from baseline of Short Form-10 score at Month 3 for subjects under 18 years old(Baseline to Month 3)
- Change from baseline of Short Form-10 score at Month 12 for subjects under 18 years old(Baseline to Month 12)
- Percentage of patients with recurrence of ear prominence(24 months)
- Change from baseline of Short Form-12 score at Month 3 for subjects over 18 years(Baseline to Month 3)
- Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 12(Baseline to Month 12)
- Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 3(Baseline to Month 3)
- Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 3(Baseline to Month 3)
- Change from baseline in maximum helix to scalp distance from before PREFOLD® insertion at Month 24(Baseline to Month 24)
- Maintenance of maximum helix to scalp distance at 12 months compared to 3 months visit post insertion of EARFOLD(Month 3 to Month 12)
- Maintenance of maximum helix to scalp distance at 24 months compared to 3 months visit post insertion of EARFOLD(Month 3 to Month 24)
- Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 3(Baseline to Month 3)
- Change in maximum helix to scalp distance from PREFOLD® insertion to post insertion distances at Month 24(Baseline to Month 24)
- Duration of EARFOLD® insertion procedure(Duration of surgery)
- Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 3(Baseline to Month 3)
- Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 12(Baseline to Month 12)
- Change from baseline pre-insertion in EAR-Q Social Function Questionnaire at Month 24(Baseline to Month 24)
- Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 12(Baseline to Month 12)
- Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 24(Baseline to Month 24)
- Return to normal activities questionnaire after EARFOLD® surgery at Month 3(Month 3)
- Change from baseline pre-insertion in EAR-Q School Function Questionnaire at Month 24(Baseline to Month 24)
- Change from baseline pre-insertion in EAR-Q Psychological Function Questionnaire at Month 12(Baseline to Month 12)
研究者
研究点 (12)
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