BD-Covered Stent for Benign Esophageal Strictures: a Safety and Feasibility Study
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 主要终点
- BD-Covered stent placement (feasibility): (1) ease of deployment at intended esophageal location and, (2) incidence of device related adverse events at moment of stent placement
研究概览
简要总结
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae
详细描述
A non-randomized prospective clinical, pilot study in a single centre assessing the safety and feasibility of the esophageal biodegradable covered stent for refractory benign esophageal strictures with or without fistulae. The follow-up will be 6 months form implantation. After 3 months a control endoscopy will take place to evaluate stent and degradation process.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects of both genders
- •Age ≥ 18 years
- •Appropriate cultural level and understanding of the study
- •Willingness to participate voluntarily in the study and give written informed consent
- •Refractory benign esophageal stricture with or without fistulae, i.e. the patient has to pass a minimum of 2 and a maximum of 10 failed esophageal dilations to the minimal diameter of 15-mm, using a pneumatic balloon dilator or Savary bougie, not complicated by or malignancy.
- •Ability to undergo periodic endoscopic follow-up.
排除标准
- •Pregnancy or breastfeeding
- •Simultaneous participation in another clinical study
- •Life expectancy of less than 12 months
- •Malignant esophageal stricture
- •Stenosis after laryngectomy, or if the distance between the upper edge of the stent is less than 2 cm from the upper esophageal sphincter
- •Undergone an esophageal stent implantation before.
研究组 & 干预措施
BD-Covered stent
Device: BD-Covered stent for refractory benign esophageal strictures with of without fistulae
干预措施: BD-Covered esophageal stent (Device)
结局指标
主要结局
BD-Covered stent placement (feasibility): (1) ease of deployment at intended esophageal location and, (2) incidence of device related adverse events at moment of stent placement
时间窗: 1 day
Technical success is defined as ease of deployment and placement of the BD-Covered stent at the required esophageal location.
Incidence of treatment associated adverse events during follow-up (safety)
时间窗: 6 months
Short term (within 7 days after treatment) and long term (after 7 days) major complications and minor complications. Major complications are defined as life threatening and severe complications such as perforation, haemorrhage, fistula formation and severe pain. Minor complications are defined as non-life threatening or moderately severe pain and gastroesophageal reflux.
次要结局
- Esophageal pain, measured with VAS during follow-up after stent placement(6 months)
- Recurrent dysphagia, measured with Ogilvie dysphagia score, during follow-up(6 months)