Clinical Investigation to Evaluate Removal of the Evolution® Esophageal Stent - Fully Covered
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 22
- 主要终点
- Number of Patients With Successful Removal of Study Stent
研究概览
简要总结
The CLARITY study is a clinical trial approved by US FDA to study the removal of the Evolution® Esophageal Stent-Fully Covered in malignant and benign indications.
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
- •Patient is diagnosed with benign or malignant stricture, fistula, perforation, or leak
- •Physician plans to remove the stent within the duration of study follow-up
排除标准
- •Patient is < 18 years of age
- •Patient is unable or unwilling to provide written informed consent or comply with follow-up schedule
- •Patient is pregnant, lactating, or planning on being pregnant within the next 6 months
- •Patient is simultaneously participating in another investigational drug or device study
- •Patient that is contraindicated to upper GI endoscopy and/or any procedure to be performed in conjunction with esophageal stent placement
- •Patient has a known hypersensitivity or contraindication to study products that, in the opinion of the investigator, cannot be adequately pre-medicated
结局指标
主要结局
Number of Patients With Successful Removal of Study Stent
时间窗: 7 days to 6 months
The study design allowed for 130 patients to be enrolled to ensure that 58 patients had an attempted endoscopic stent removal between 7 days and 6 months in order to assess the primary measure as per sample size calculation. Therefore, the first 58 patients (malignant or benign lesions) with data submitted regarding attempted endoscopic stent removal are included in this outcome measure. Successful stent removal is one in which the study stent is completely removed from the patient during a single endoscopic procedure with the wire mesh integrity maintained such that the stent can be removed in one contiguous piece. Additionally, successful stent removal includes no tissue damage or hemorrhage visible during the retrieval procedure that is both related to the endoscopic stent removal and requires immediate treatment.
次要结局
- Number of Patients With Benign Indications That Achieved Clinical Success(7 days)