NCT01337206已完成不适用
Evaluation of the Effectiveness of the SX ELLA Esophageal Degradable BD (BD Stent) Stent System
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 15
- 主要终点
- The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent
研究概览
简要总结
The SX-ELLA Stent Esophageal Degradable BD (BD Stent) is designed for dilation of benign esophageal lesions, namely: (1) stenosis (peptic, anastomotic or caustic) refractory to standard therapy, (2) achalasia refractory to standard therapy.
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
- •A recurrent benign esophageal stricture due to all causes (surgery, radiation therapy, corrosive ingestion, peptic injury, PDT, or other ablative therapy)
排除标准
- •Patient < 18 years old
- •Patient is unwilling or unable to sign and date the informed consent
- •Patient is unwilling or unable to comply with the follow-up schedule
- •Patient is pregnant, breast-feeding, or planning to become pregnant in the next 12 months
- •Patient is simultaneously participating in another drug or device study or the patient has completed the follow-up phase for the primary objective of any previous study less than 30 days prior to enrollment in this study
- •Patient with a life expectancy < 12 months
结局指标
主要结局
The average number of dilations per patient within 3 months / 6 months following placement of an ELLA stent
时间窗: 3 - 6 months
次要结局
- Number of patients remaining dysphagia and stricture free within 6 and 12 months after inclusion(6 - 12 months)
- Time to dilation of recurrent stricture(6 - 12 months)
- Serious and minor adverse events with possible or likely relation to the study Intervention(6 - 12 months)
- Direct medicals costs: procedures, secondary interventions(6 - 12 months)
- Time to recurrent significant dysphagia(6 - 12 months)
- Quality of Life(6 - 12 months)
- 6 months and 12 months incidence of repeat dilation(6 - 12 months)
- Technical success(6 - 12 months)
- Assessment of presence of gold markers within the region of the esophagus at 3 months, if possible(6 - 12 months)
研究者
研究点 (15)
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