Clinical Luminal Endoscopic Assessment of a Novel Suction (CLEANS) Technique for the Treatment of Esophageal Food Impaction
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Food Bolus Clearance
研究概览
简要总结
This clinical investigation is to evaluate the safety, performance, and efficacy of a novel endoscopic technique for resolving esophageal food impactions by using a novel hollow suction catheter, Piranha GI Aspiration Catheter, to core out and suction food away from the center of an impaction. This technique includes hollowing out the center of the impaction, thus reducing the volume of the food bolus in the center, allowing the food to collapse into the hollow center, and then allowing for spontaneous food passage into the stomach. The study design is based on the experience of the investigators and the general knowledge of the food impaction field. In addition, consideration was given to previous studies of endoscopic treatments for esophageal food impaction.
详细描述
CLEANS Synopsis Protocol Number 001 Procedure/Device Endoscopy using a standard suction catheter Sponsor Biomerics Advanced Catheter Primary Objective The objective of the trial is to evaluate the efficacy of a novel coring/suctioning technique for esophageal food impactions using a suction catheter. Data obtained from this clinical trial will be used to support this technique for standard clinical use.
Proposed Use Esophageal food impactions. Study Design This is a single-arm, open label observational trial designed to assess the efficacy of a novel suction technique for the treatment of esophageal food impactions. The endoscopists performing the procedure are not blinded to the treatment.
Follow-Up Schedule There is no follow-up after the procedure. Number of Subjects/Sites 40 non-randomized subjects, 10 at 4 investigational sites.
Exclusion Criteria
- Unable to tolerate an endoscopic procedure.
- Has a condition that could lead to significant postoperative complications, including current infection, anticoagulant use (Note: this is a relative exclusion since these patients still may require endoscopic food clearance).
- Enrolled in a concurrent clinical food impaction trial.
- Inability to comply with the consent process (as determined by investigator).
- Pregnant.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Esophageal food impaction requiring endoscopic intervention.
- •Male or female.
- •Willing to participate and capable of understanding the clinical study procedure and giving informed consent.
排除标准
- •Unable to tolerate an endoscopic procedure.
- •Has a condition that could lead to significant postoperative complications, including current infection, anticoagulant use (Note: this is a relative exclusion since these patients still may require endoscopic food clearance).
- •Enrolled in a concurrent clinical food impaction trial.
- •Inability to comply with the consent process (as determined by investigator).
- •Pregnant.
结局指标
主要结局
Food Bolus Clearance
时间窗: During procedure
The first primary endpoint will be to assess the complete food bolus clearance rate.
Time to Clearance
时间窗: During procedure
The second will be time to complete clearance.
次要结局
- Ease of Use(Immediately following procedure)
- Satisfaction(Immediately following procedure)