A Multi-Center, Prospective, Evaluation of the Use of a Fully Covered Metal Stent (FCMS) for the Treatment of Refractory Benign Esophageal Strictures Caused by Caustic Ingestion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1
- 试验地点
- 4
- 主要终点
- Clinical Success
研究概览
简要总结
The purpose of this study is to establish clinical proof of concept of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory benign esophageal strictures caused by caustic ingestion.
详细描述
The purpose of this study is to establish clinical proof of concept of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory benign esophageal strictures caused by caustic ingestion. Also to collect data in support of a hypothesis required to prospectively document the safety and effectiveness of temporary indwell of the WallFlex™ Esophageal Fully Covered Metal Stent (FCMS) compared to repeated Bougie Dilation for the treatment of refractory benign esophageal strictures caused by caustic ingestion.
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
- 是
入选标准
- •Availability of medical history pertaining to dysphagia score prior to and during the preceding SECSER.
- •Availability of patient history pertaining to weight prior to and at completion of SECSER.
- •Benign esophageal stricture caused by caustic ingestion 12 or more weeks prior to enrollment.
- •Single esophageal stricture or multiple esophageal stricture over a length < 6 cm.
- •Having completed the SECSER consisting of 3 dilations intended to reach 15 mm each, separated by 2 weeks, followed by 3 dilations intended to reach 15 mm each with steroid injections, separated by 2 weeks. The dilations may be performed using Bougie or balloon dilation at the discretion of the investigator.
- •Refractory stricture defined as recurrence of stricture with associated dysphagia within 6 months after completion of SECSER.
- •Dysphagia score of 2 (ability to swallow semi-solid foods), 3 (ability to swallow liquids only) or 4 (unable to swallow liquids) at baseline.
- •Unable to pass a standard endoscope (approximately 9.8 mm diameter).
- •Age 18 years or older.
- •Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
排除标准
- •Stricture within 2 cm of the upper esophageal sphincter.
- •Concomitant Esophageal ulcerations.
- •Prior esophageal stent placements.
- •Concurrent gastric and/or duodenal obstruction.
- •Patients with prior full or partial gastrectomy.
- •Sensitivity to any components of the stent or delivery system.
- •Concurrent medical condition that would affect the investigator's ability to evaluate the patient's condition or could compromise patient safety.
- •Participation in a clinical trial evaluating an investigational device within 3 months prior to enrollment in this study.
结局指标
主要结局
Clinical Success
时间窗: From stent placement on day 0 to 6 months after stent removal
Clinical success consisting of stent tolerability and adequate ability to sustain nutrition to 6 months after stent removal. Stent tolerability defined as absence of pain-related stent removal. Adequate ability to sustain nutrition defined as absence of dysphagia-related reintervention.
次要结局
- Stent Removal Success(Stent removal at Week 8 (±7 days))
- Dysphagia Score During Stent Treatment Compared to Score During Proceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER)(Dysphagia score at SECSER was measured prior to baseline. Dysphagia score during stent treatment was measured from stent placement on day 0 to end of study at Week 32)
- Number of Stent Migration With or Without Related Adverse Events(From stent placement on Day 0 to end of study at Week 32.)
- Stent Placement Success(Stent placement on Day 0)
- Change in Patient's Report on Pain Compared to Baseline(From baseline to stent removal at Week 8 (±7 days))
- Time to Recurrence of Stricture(From stent placement on Day 0 to end of study at Week 32.)
- Change in Patient Weight Compared to Baseline(From stent placement on Day 0 to end of study at Week 32.)
- Change in Patient Weight During Stent Treatment Compared to Weight Gain During Preceding SECSER(From stent placement on Day 0 to end of study at Week 32.)
- Change of Pain Medication Intake From Baseline(From baseline to stent removal at Week 8 (±7 days))
- Change in Dysphagia Score Compared to Baseline(From stent placement on day 0 to end of study at Week 32.)
- Change in Quality of Life (QOL) Compared to Baseline(From stent placement on Day 0 to end of study at Week 32)
- Occurrence of Adverse Events(From stent placement on Day 0 to end of study at Week 32.)