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 Ingestion
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Clinical Success consisting of stent tolerability and adequate ability to sustain nutrition to 6 months after stent removal.
研究概览
简要总结
To establish clinical proof of concept of temporary placement of the WallFlexâ„¢ Esophageal Fully Covered Metal Stent (FCMS) for the treatment of refractory benign esophageal strictures caused by caustic ingestion. xml:namespace prefix = o ns = "urn:schemas-microsoft-com:office:office" /
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
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Availability of medical history pertaining to dysphagia score prior to and during the preceeding 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 (approx.
- •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 consisting of stent tolerability and adequate ability to sustain nutrition to 6 months after stent removal.
时间窗: The proposed duration of the study is approximately 21 months, allowing 12 months for enrollment; 2-3 months of stent indwell plus 6 months after stent removal.
Stent tolerability defined as completion of planned stent indwell.
时间窗: The proposed duration of the study is approximately 21 months, allowing 12 months for enrollment; 2-3 months of stent indwell plus 6 months after stent removal.
Adequate ability to sustatin nutrition defined as absence of dysphagia-related reintervention.
时间窗: The proposed duration of the study is approximately 21 months, allowing 12 months for enrollment; 2-3 months of stent indwell plus 6 months after stent removal.
次要结局
- Technical stent placement success defined as the ability to deploy the stent in satisfactory position across the stricture.(Stent placement procedure)
- Dysphagia score during stent treatment compared to dysphagia score during preceeding Standardized Esophageal Caustic Stricture Endoscopic Treatment Regimen (SECSER).(Stent placement through removal)
- Time to recurrence of stricture, defined as inability of a normal diameter gastroscope (9.8 mm) to pass the stricture.(Entire Study)
- Incidence of stent migration with or without related Adverse Events (AE).(Stent placement through removal)
- Number of reinterventions from enrollment to end of study, excluding the stent placement and stent removal procedures.(Entire Study)
- Stent removal success defined by the ability to remove the stent endoscopically without serious stent removal related complications.(Stent removal procedure)
- Patient’s Report on Pain compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until stent removal.(Stent placement through removal)
- Improvement of dysphagia score compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until end of study.(Entire Study)
- Quality Of Life (QOL) improvement compared to Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until end of study.(Entire Study)
- Change of pain medication intake from Baseline: Day 2, week 1, week 2, and thereafter every 2 weeks until stent removal.(Stent placement through removal)
- Occurrence and severity of adverse events related to the stent and/or the stent placement or stent removal procedure and of all serious adverse events throughout the duration of the study.(Entire Study)