Prospective, Multicenter, Single Blind, Randomized Study Comparing the EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent With Valve to the EndoMAXX Fully Covered Esophageal Stent for Malignant Strictures Requiring Stent Placement Across the Gastroesophageal Junction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 13
- 主要终点
- Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment
研究概览
简要总结
This is a prospective, single blinded, randomized study of EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve for the treatment of malignant strictures of the lower esophagus. The purpose of this study is to evaluate improvement of dysphagia due to esophageal stricture with EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve (investigational device) compared to the EndoMAXX Fully Covered Esophageal Stent (reference device).
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
- Single (Outcomes Assessor)
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 18 years of age or older
- •Patient (or legal representative) is able to understand and provide signed informed consent
- •Patient has a malignant stricture of the distal esophagus or gastric cardia requiring stent placement across the gastroesophageal junction.
排除标准
- •Patient is unwilling or unable to comply with the follow-up schedule
- •Patient is contraindicated for endoscopic procedure for any reason
- •Patient presents with esophagorespiratory fistula
- •Patient has previously undergone esophageal stenting or esophagectomy
- •Female patient is pregnant, breastfeeding, or premenopausal and not using an effective method of contraception
- •Patient's esophageal tumor length exceeds that which can be treated with a single stent (maximum lesion length 9.5cm)
- •Removal of stent is scheduled to occur within six months
- •Patient has trouble swallowing or experiences regurgitation for reasons which are not related to his/her esophageal cancer
- •Any other factor identified by the Investigator that would disqualify the prospective patient from participation in the study including but not limited to coagulative disorders and anesthetic risk.
研究组 & 干预措施
EndoMAXX
EndoMAXX Fully Covered Esophageal Stent
干预措施: EndoMAXX (Device)
EndoMAXX Endoluminal Valve Technology (EVT)
EndoMAXX Endoluminal Valve Technology (EVT) Fully Covered Esophageal Stent with Valve
干预措施: EndoMAXX Endoluminal Valve Technology (EVT) (Device)
结局指标
主要结局
Mellow and Pinkas Dysphagia Score at Baseline and 2 Weeks Following the Treatment
时间窗: 2 Weeks Following Treatment
The primary endpoint is to evaluate improvement of dysphagia due to esophageal strictures at 2 weeks following treatment. Scale: 0 = able to eat normal diet / no dysphagia. 1. = able to swallow some solid foods 2. = able to swallow only semi solid foods 3. = able to swallow liquids only 4. = unable to swallow anything / total dysphagia
次要结局
- GERD-HRQL(4 Weeks Following Treament)