Evaluation of PillCam® Express Capsule Endoscopy Delivery System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 6
- 主要终点
- Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System.
详细描述
Natural ingestion of a wireless capsule endoscope (e.g. PillCam™ SB) is contraindicated in subjects with oropharyngeal or mechanical dysphagia, gastroparesis and known or suspected anatomical abnormalities. In addition, ingestion of a wireless capsule endoscope may be challenging in the pediatric population. The PillCam® Express Capsule Endoscopy Delivery System is intended to provide physicians with the capability to place capsules in the proximal duodenum using the accessory channel of a standard endoscope.
The PillCam™ SB capsule to be used in this study was cleared by the FDA in August 2001 for small bowel evaluation. It has been ingested to date by more than 1,000,000 people worldwide and is well accepted by subjects and physicians as well as the professional societies.
Further details of the PillCam®Express Capsule Endoscopy Delivery System can be found in the device description section.
This study is designed to evaluate the performance and safety of the Capsule Endoscopy Delivery System in subjects indicated to undergo a standard Esophagogastroduodenoscopy (EGD) endoscopy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 2 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 2 years
- •Subject scheduled for EGD endoscopy with a 2.8 mm (or greater) working channel
排除标准
- •Subject is known or is suspected to suffer from bowel obstruction or bowel perforation at the time of presentation
- •Subject has history of UGI tract surgery (e.g., Billroth I, Billroth II, esophagectomy, gastrectomy, bariatric procedure)
- •Presence of an electro-medical device (pacemaker or internal cardiac defibrillator)
- •Subject is pregnant
- •Subject is expected to undergo a MRI examination within 7 days after ingestion of the capsule
- •Subject has known allergy to conscious sedation medications
- •Subject or legal guardian is not able to provide written informed consent
结局指标
主要结局
Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System
时间窗: up to 7 days
The number of capsules that successfully were in the duodenum as indicated by video images
次要结局
- Physician's Subjective Assessment of the Ease of Capsule Placement(7 days)